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Duración y volumen de administración de líquidos en pacientes con hemorragia

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Antecedentes

El tratamiento del shock hemorrágico implica mantener la presión arterial y la perfusión a los tejidos hasta que la hemorragia esté controlada. Se han utilizado diferentes estrategias de reanimación para mantener la presión arterial en pacientes con traumatismo hasta que la hemorragia esté controlada. Sin embargo, aunque se puede prevenir el shock al mantener la presión arterial, se puede agravar la hemorragia.

Objetivos

Examinar el efecto sobre la mortalidad y los tiempos de coagulación de dos estrategias de administración de fluidos intravenosos en el tratamiento de la hipovolemia hemorrágica, la administración temprana en comparación con la tardía y la mayor en comparación con el menor volumen de fluido administrado.

Métodos de búsqueda

Se realizaron búsquedas en el Registro Especializado del Grupo Cochrane de Lesiones (Cochrane Injuries Group), en el Registro Cochrane Central de Ensayos Controlados (Cochrane Central Register of Controlled Trials, CENTRAL) en The Cochrane Library, en Ovid MEDLINE(R), en Ovid MEDLINE(R) In‐Process & Other Non‐Indexed Citations, en Ovid MEDLINE(R) Daily y en Ovid OLDMEDLINE(R), en Embase Classic + Embase (OvidSP), en ISI Web of Science (SCI‐Expanded y CPCI‐S) y en registros de ensayos clínicos. Se verificaron las listas de referencias de los artículos identificados y se contactó con los autores y expertos en el tema. La búsqueda más reciente se realizó el 5 de febrero de 2014.

Criterios de selección

Ensayos aleatorizados del momento adecuado y volumen de administración de líquidos por vía intravenosa a pacientes con traumatismo hemorrágico. Se excluyeron los ensayos en los que se compararon distintos tipos de líquidos administrados por vía intravenosa.

Obtención y análisis de los datos

Dos autores de la revisión extrajeron los datos de forma independiente y evaluaron la calidad de los ensayos.

Resultados principales

En esta revisión se incluyeron seis ensayos con un total de 2128 personas. Los resultados no se combinaron cuantitativamente debido a que las intervenciones y las poblaciones de pacientes eran muy diferentes.

Administración de líquidos temprana versus tardía
Tres ensayos informaron datos de mortalidad y dos informaron datos de coagulación.

En el primer ensayo (n = 598) el riesgo relativo (RR) de muerte con administración de líquidos temprana fue de 1,26 (IC del 95%: 1,00 a 1,58). Las diferencias de promedios ponderados (DPP) para el tiempo de protrombina y el tiempo de tromboplastina parcial fueron de 2,7 (IC del 95%: 0,9 a 4,5) y 4,3 (IC del 4.3%: 1,74 a 6,9) segundos, respectivamente.
En el segundo ensayo (n = 50) el RR de muerte con transfusión de sangre temprana fue de 5,4 (IC del 95%: 0,3 a 107,1). La DPP para el tiempo de tromboplastina parcial fue de 7,0 (IC del 95%: 6,0 a 8,0) segundos. En el tercer ensayo (n = 1309) el RR de muerte con administración de líquidos temprana fue de 1,06 (IC del 95%: 0,77 a 1,47).

Administración de un volumen de líquidos mayor versus menor
Tres ensayos informaron sobre la mortalidad y uno sobre los datos de coagulación.

En el primer ensayo (n=36) el RR de muerte con reanimación con un volumen de líquidos mayor fue de 0,80 (IC del 95%: 0,28 a 22,29). El tiempo de protrombina y el tiempo de tromboplastina parcial fueron de 14, 8 y 47,3 segundos en los pacientes que recibieron un volumen de líquidos mayor, en comparación con 13,9 y 35,1 segundos en el grupo de comparación.
En el segundo ensayo (n=110) el RR de muerte con un objetivo de reanimación de presión arterial sistólica alta (100mmHg) mantenida con un volumen de líquidos mayor en comparación con un objetivo de reanimación de presión arterial sistólica baja (70mmHg) mantenida con un volumen de líquidos menor fue de 1,00 (IC del 95%: 0,26 a 3,81). En el tercer ensayo (n=25) no ocurrieron muertes.

Conclusiones de los autores

No se encontró evidencia de ensayos controlados aleatorizados que apoyen o no la administración temprana o de un volumen de líquidos mayor por vía intravenosa en una hemorragia no controlada. Continua la incertidumbre acerca de la mejor estrategia de administración de líquidos en los pacientes con traumatismo hemorrágico. Se necesitan más ensayos controlados aleatorizados para identificar la estrategia de reanimación con líquidos más efectiva.

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Resumen en términos sencillos

Variando el momento adecuado o el volumen de los fluidos intravenosos que se administran a los pacientes con hemorragias no controladas debido a lesiones

Aproximadamente un tercio de las muertes por lesiones se deben al shock por la pérdida de sangre. Por lo tanto, es importante prevenir el shock en las personas con hemorragia no controlada, y generalmente esto se hace por medio de la administración de líquidos por vía intravenosa. El objetivo es mantener la presión arterial y reducir el daño a los tejidos. La composición de estos fluidos puede variar, y se han realizado revisiones sistemáticas que comparan los diferentes tipos de fluidos, pero el volumen de fluido administrado y el momento en que se administra también puede variar. Aún no está claro qué momento y qué volumen son los más efectivos.

Los autores buscaron informes de investigación médica relevantes y encontraron seis ensayos controlados aleatorizados con un total de 2128 personas. En cada estudio, las personas con hemorragias no controladas fueron asignadas al azar para recibir un tratamiento u otro. Tres estudios trataron sobre la cantidad de líquido administrado (más o menos), y tres estudios trataron sobre la administración de líquido en diferentes momentos después de la lesión (tarde o temprano). Los autores se interesaron en averiguar qué tratamientos eran mejores, para reducir las muertes y permitir la coagulación de la sangre. La coagulación de la sangre se midió por el tiempo de protrombina y el tiempo parcial de tromboplastina durante la administración de fluidos.

La revisión de los ensayos encontró que no hay certeza acerca del mejor momento para administrar líquidos y acerca de qué volumen de líquidos se debe administrar. Aunque un mayor volumen de líquidos mantiene la presión arterial, también puede agravar la hemorragia al diluir los factores de coagulación en la sangre.

La primera versión de esta revisión se publicó en el 2000 e incluyó estos seis ensayos. Los autores buscaron nuevos estudios pertinentes en 2003, 2008 y 2014, pero no se encontró ninguno. Los autores buscarán estudios en el 2020, y cualquier información nueva se incorporará a la revisión.

Authors' conclusions

Implications for practice

We found no evidence for or against the use of early or larger volume intravenous fluid administration in uncontrolled haemorrhage. There is uncertainty about the effectiveness of fluid resuscitation in patients with bleeding following trauma.

Implications for research

Large, well concealed, randomised controlled trials are urgently needed to establish the optimal fluid resuscitation strategy in haemorrhaging trauma patients, with a focus on specific types of injuries likely to benefit from the appropriate resuscitation strategy in terms of timing and volume of fluids given.

Background

In 1990 approximately five million people died worldwide as a result of injury (Murray 1996). For people younger than 35 years, injury is now the leading cause of death. Nevertheless, the global epidemic of injury is only beginning. It is estimated that by 2020, deaths from injury will have increased from 5.1 million to 8.4 million (Murray 1997). About one third of injury deaths are due to haemorrhagic shock (Deakin 1994). Acute blood loss following injury leads to a reduction in tissue perfusion and tissue oxygen delivery that, if prolonged, cause lactic acidosis and organ failure. Treatment of haemorrhagic shock involves maintaining blood pressure and tissue perfusion until the bleeding is controlled. Over the past 50 years a number of resuscitation strategies have been used to maintain the blood pressure in trauma patients until bleeding is controlled. The evidence for the effectiveness of these approaches has been the subject of a number of systematic reviews by the Cochrane Injuries Group and by others.

Pre‐hospital use of medical anti‐shock trousers

Medical anti‐shock trousers (MAST) were first used in the Vietnam War to stabilise patients with haemorrhagic shock during transportation. After the war, MAST became widely used in the care of bleeding trauma patients. MAST increase blood pressure by compressing the blood vessels in the legs, thus increasing systemic vascular resistance, and by shunting blood from the lower body to the brain, heart and lungs. It was hoped that by increasing venous return to the heart, MAST would maintain the blood flow to vital organs until definitive care was given. Nevertheless, a systematic review of randomised controlled trials of MAST use in pre‐hospital trauma care provided no evidence that MAST increase survival, and a suggestion that they may increase the risk of death. The pooled relative risk of death with MAST was 1.13 (95% CI 0.97 to 1.32) (Roberts 1999).

Paramedic ambulance crews

In high‐income countries, an increasing number of ambulance crews include a paramedic trained in advance life support. Paramedics receive extra training in intubation, intravenous cannulation, and the administration of intravenous fluids. Only a small proportion of paramedic‐attended trauma patients require intubation (1%), but a larger proportion (18%) receive intravenous fluids (Nicholl 1998). Because of the strong conviction amongst the public and medical profession that paramedic intervention is beneficial, it has been difficult to conduct randomised controlled trials comparing paramedic and non‐paramedic trauma care. However, a review and meta‐analysis of four cohort studies gave a significantly increased (P = 0.03) risk of death in paramedic‐attended patients (relative risk (RR) 1.26) (Nicholl 1998). Because of the potential for confounding by injury severity, the validity of inferences from cohort studies must be questioned. Nevertheless, the results are consistent with the hypothesis that efforts by paramedics to raise the blood pressure of bleeding trauma patients may be counterproductive.

Colloid fluid resuscitation

Intravenous fluid administration, with colloid or crystalloid solutions, is the mainstay of the non‐surgical management of bleeding trauma patients. Colloids are better than crystalloid solutions in expanding the circulation because they are retained within the blood vessels to a greater extent. Crystalloid solutions rapidly leak out of the blood vessels into the interstitial spaces. After a colloid infusion, the increase in the circulating volume is about the same as the volume of colloid infused, whereas only about one quarter of the volume of a crystalloid infusion remains in the blood vessels (Weil 1999). Although colloids are effective in expanding the circulation there is no evidence that this improves outcomes in critically ill patients (Perel 2013).

The systematic reviews of MAST, paramedic resuscitation and colloid administration call into question the benefits of raising the blood pressure in bleeding trauma patients. But by what mechanisms could fluid resuscitation adversely affect the outcome? Stern, using a swine model of near‐fatal haemorrhage, found that attempts to restore blood pressure with crystalloid resulted in increased haemorrhage volume and markedly higher mortality (Stern 1993). It was postulated that the increased pulse pressure from crystalloid resuscitation might cause the mechanical disruption of blood clots and worsen bleeding. It has also been proposed that fluid administration might worsen bleeding by diluting clotting factors. In view of the concerns raised by the previous systematic reviews, and by the results of animal models of haemorrhagic hypovolaemia, we have conducted a systematic review of the effect on mortality of early versus delayed fluid resuscitation, and of larger versus smaller fluid volumes.

Objectives

To examine the effect on mortality and coagulation times of two intravenous fluid administration strategies in the management of haemorrhagic hypovolaemia, early compared to delayed administration and larger compared to smaller volume of fluid administered.

Methods

Criteria for considering studies for this review

Types of studies

All randomised controlled trials of the timing or volume of intravenous fluid administration in haemorrhagic hypovolaemia.

Types of participants

People of all ages with haemorrhagic hypovolaemia of traumatic or non‐traumatic origin. Because the physiological response to bleeding and to fluid resuscitation is likely to be similar among people with internal bleeding (for example a bleeding peptic ulcer) and those with external bleeding (for example penetrating trauma), both types of participants were included.

Types of interventions

Intravenous fluids including crystalloid solutions, colloids, plasma and blood. Trials in which the timing or volume of fluid administration was confounded by the type of intravenous fluid given, for example a trial comparing the administration of 1000 ml of colloid with 500 ml of blood, were excluded.

Types of outcome measures

Primary outcomes

  • Mortality from all causes at the end of the follow‐up period scheduled for each trial

We sought mortality data in simple categorical form, and we did not extract data on time to death. If a report did not include the numbers of deaths in each group, we sought these data from the authors.

Secondary outcomes

  • Prothrombin time

  • Partial thromboplastin time during fluid administration

Search methods for identification of studies

In order to reduce publication and retrieval bias we did not restrict our search by language, date or publication status.

Electronic searches

The Cochrane Injuries Group Trials Search Co‐ordinator searched the following:

  1. Cochrane Injuries Group Specialised Register (31st January 2014);

  2. Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2014, Issue 1 of 12);

  3. Ovid MEDLINE(R), Ovid MEDLINE(R) In‐Process & Other Non‐Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R (1946 to 5th February 2014);

  4. Embase Classic + Embase (OvidSP) (1947 to 5th February 2014);

  5. ISI Web of Science: Science Citation Index Expanded (SCI‐Expanded) (1970 to February 2014);

  6. ISI Web of Science: Conference Proceedings Citation Index‐Science (CPCI‐S) (1990 to February 2014).

Search notes and strategies can be found in Appendix 1.

Searching other resources

We checked the reference lists of all included studies and contacted authors and experts in the field. The Science Citation Index was checked for eligible papers that cited two of the trials (Bickell 1994; Blair 1986) included in this review.

Data collection and analysis

Selection of studies

For the original version of the review, one author (IK) examined the electronic search results for reports of possibly relevant trials and these reports were then retrieved in full. The first review author (IK) also contacted experts in the field for unpublished and ongoing trials. A second review author (FB) examined 10% of the electronic search results to check for agreement on eligibility criteria. Two review authors (FB, IK) applied the selection criteria independently to the trial reports, resolving disagreements by discussion with a third (IR).

For the 2014 update, PC screened all the search results. IK, IR and FB each screened one third of the search results for the purpose of dual screening.

Data extraction and management

For the original version of the review, two authors (IK, FB) independently extracted information on the following: method of allocation concealment, number of randomised patients, types of participants and the interventions, loss to follow‐up and length of follow‐up. The outcome data sought were numbers of deaths, prothrombin time and partial thromboplastin time. The authors were not blinded to the study authors or journal when doing this. Results were compared and any differences resolved by discussion.

Where there was insufficient information in the published report we attempted to contact the authors for clarification.

Assessment of risk of bias in included studies

Since there is evidence that the quality of allocation concealment particularly affects the results of studies, two authors (IK, FB) scored this quality on the scale used by Higgins 2011 as shown below, assigning 'High risk of bias' to poorest quality and 'Low risk of bias' to best quality trials.

  • Low risk of bias: trials deemed to have taken adequate measures to conceal allocation (i.e. central randomisation; serially numbered, opaque, sealed envelopes; or other description that contained elements convincing the review authors of concealment).

  • Unclear risk of bias: trials in which the authors either did not report an allocation concealment approach at all or reported an approach that did not fall into one of the other categories.

  • High risk of bias: trials in which concealment was inadequate (such as alternation or reference to case record numbers or to dates of birth).

Where the method used to conceal allocation was not clearly reported, the author(s) were contacted, if possible, for clarification. We then compared the judgement assigned and resolved differences by discussion.

Data synthesis

The following comparisons were made:

  • early versus delayed intravenous fluids administration;

  • larger versus smaller volumes of intravenous fluids administration.

The relative risk of death and 95% confidence interval (95% CI) were calculated, such that a relative risk of more than 1 indicated a higher risk of death in the first group named. The relative risk was chosen as it is more readily applied to the clinical situation. The weighted mean difference was calculated for coagulation times.

Because of differences in the types of patients and in the nature of the trial interventions we did not pool the data in our analysis.

Results

Description of studies

The six included studies were retrieved by the original search. The most recent search retrieved 1221 references (Figure 1) and all search results were scanned by two review authors for potentially relevant studies. No new trials that met the inclusion criteria were identified from these updated search results.


Study flow diagram.

Study flow diagram.

A. Early versus delayed intravenous fluids administration

Bickell 1994
This trial compared early versus delayed administration of Ringer's acetate solution, an isotonic crystalloid, in patients with penetrating torso injuries during the pre‐hospital phase. Participants were adults over 16 years of age, with gunshot or stab wounds to the torso, and who had a systolic blood pressure of < 90 mm Hg. Participants with head injury, a Revised Trauma Score of zero or minor injuries were excluded. During the trial, 22 patients (8%) in the delayed resuscitation group were inadvertently given fluid prior to surgery in violation of the protocol. Follow‐up was until hospital discharge.

Blair 1986
This trial compared early versus delayed blood transfusion in patients with acute gastrointestinal haemorrhage during the first 24 hours after admission. Patients with oesophageal varices were excluded because of abnormal coagulation related to liver diseases. Follow‐up was until hospital discharge.

Turner 2000
This trial compared early versus no or delayed fluid administration in trauma patients. Participants were all trauma patients with moderate to severe injuries, over the age of 16 years. Patients who were pregnant or without vital signs were excluded. The fluids given were crystalloids. Protocol compliance was poor with 31% of patients in the early fluid group receiving fluids and 80% of the delayed or no fluid group not given fluids. Follow‐up was for six months.

B. Larger versus smaller volume of intravenous fluids administration

Dunham 1991
This trial compared fluid resuscitation using the rapid infusion system and conventional fluid administration method in trauma patients during the first 24 hours of admission. Participants were between 14 and 60 years of age and had a systolic blood pressure of < 90 mm Hg. Patients with a Glasgow Coma Score of < 5, cardiac arrest, quadriplegia and myocardial infarct on admission were excluded. Fluids given included red blood cells, platelets, fresh frozen plasma and crystalloids. Follow‐up was until hospital discharge.

Dutton 2002
This trial compared the maintenance of target systolic blood pressures of 70 and 100 mm Hg respectively with fluid restriction (Plasma, Plasmalyte‐A and red blood cells in the first 24 hours) in patients with blunt and penetrating trauma injuries. All participants suffered haemorrhagic shock with a systolic blood pressure (SBP) of < 90 mm Hg. Patients with head or spinal cord injury were excluded. The length of the follow‐up period was until death or hospital discharge.

Fortune 1987
This trial compared the maintenance of the haematocrit at 30% and 40% respectively with blood transfusion in patients following acute injuries and haemorrhage, during the first 72 hours of admission. All participants had sustained Class III or IV haemorrhage with a systolic blood pressure of < 90 mm Hg, heart rate > 100 beats per minute. Follow‐up was for three days.

Risk of bias in included studies

A. Early versus delayed intravenous fluids administration

Bickell 1994
Randomisation was by alternate day allocation, which allowed foreknowledge of treatment allocation. Data were analysed as randomised, on an intention‐to‐treat basis. Blinding of outcome assessment was not stated. There was no loss to follow‐up.

Blair 1986
Contact with the author of this trial established the adequacy of the randomisation method used. Allocation was by opening sealed envelopes at the time of patient presentation. Blinding of outcome assessment was not stated. Data were analysed as randomised, on an intention‐to‐treat basis. There was no loss to follow‐up.

Turner 2000
Paramedics rather than trauma patients were randomised using computer‐generated random numbers, stratified by base stations. The paramedics crossed over to the alternate fluid protocol halfway through the trial and they were not blinded. Data were analysed as randomised, on an intention‐to‐treat basis. There was no blinding of outcome assessment.

B. Larger versus smaller volume of intravenous fluids administration

Dunham 1991
The methods of randomisation and allocation concealment were unclear. Blinding of outcome assessment was not stated. Data on eight patients who died during the first 12 hours were excluded from the analysis except for the outcome death.

Dutton 2002
Randomisation was by selecting the next numbered envelope from a supply maintained in the Trauma Resuscitation Unit. The envelopes were made up in batches of 20 (10 to each group), thoroughly mixed and then numbered for selection. Allocation was blinded to all unit personnel prior to enrolment. Only the patients were blinded to the allocation in this trial after randomisation. Data were analysed as randomised, on an intention‐to‐treat basis. Blinding of outcome assessment was not stated. There was no loss to follow‐up.

Fortune 1987
Contact with the co‐author of this trial established the adequacy of the randomisation method used. Sequences of random allocations were generated by a statistician not involved with the study, in sets of sealed opaque envelopes, differentiated by sex and age groups. Both patients and physicians had no prior knowledge of which arm the patient would be assigned to. Blinding of outcome assessment was not stated. There was no loss to follow‐up.

The characteristics of each trial are listed in Characteristics of included studies.

Effects of interventions

A. Early versus delayed fluid administration

One trial (Bickell 1994) reported mortality and coagulation time for a total of 598 hypotensive trauma patients with penetrating torso injuries. Mortality was 116/309 (38%) in the early and 86/289 (30%) in the delayed administration group. The relative risk for death with early fluid administration was 1.26 (95% CI 1.00 to 1.58). Prothrombin time and partial thromboplastin time were 14.1 and 31.8 seconds in the early administration group as compared to 11.4 and 27.5 seconds in the delayed administration group. The weighted mean differences (WMD) for prothrombin time and partial thromboplastin time were 2.7 (95% CI 0.90 to 4.5) and 4.3 seconds (95% CI 1.7 to 6.9) respectively.

One trial (Blair 1986) reported mortality and coagulation time for a total of 50 hypotensive patients with acute upper gastrointestinal haemorrhage. Mortality was 2/24 (8%) in the early as compared to 0/26 (0%) in the delayed transfusion group. The relative risk for death with early blood transfusion was 5.4 (95% CI 0.3 to 107.1). The activated partial thromboplastin time was 48 in the early group as compared to 41 seconds in the delayed administration group. The WMD for partial thromboplastin time was 7.0 seconds (95% CI 6.0 to 8.0).

In one trial (Turner 2000) on a total of 1309 trauma patients, mortality was 73/699 (10.4%) in the early as compared to 60/610 (9.8%) in the delayed or no fluid administration group. The relative risk for death with early fluid administration was 1.06 (95% CI 0.77 to 1.47). There were no data on coagulation times.

B. Larger versus smaller volume of fluid administration

One trial (Dunham 1991) reported mortality and coagulation time for a total of 36 hypotensive trauma patients. Mortality was 5/20 (25%) in the group who received a larger volume of fluids, administered conventionally, as compared to 5/16 (31%) in the group who received a smaller volume of fluids administered using the Rapid Infusion System. The relative risk for death was 0.80 (95% CI 0.28 to 2.29). Prothrombin time and partial thromboplastin time were 14.8 and 47.3 seconds in the group who received a larger volume of fluid compared to 13.9 and 35.1 seconds in the comparison group.

In one trial (Dutton 2002) on a total of 110 hypotensive patients with blunt and penetrating injuries, mortality was 4/55 (7.3%) in the group administered a larger volume and 4/55 (7.3%) in the group administered a smaller volume (1000 ml less than in the intervention group). The relative risk for death was 1.00 (95% CI 0.26 to 3.81). There were no data on coagulation times.

In one trial (Fortune 1987) on a total of 25 hypotensive patients with acute injury and haemorrhage, there were no data on mortality in either of the groups administered larger or smaller volumes of blood. Contact with the co‐author established that there were no deaths in either group. There were no data on coagulation times.

Discussion

This review found insufficient evidence for or against the use of early or larger volume fluid resuscitation in the treatment of uncontrolled haemorrhage. While vigorous fluid resuscitation may be life‐saving in some patients, results from clinical trials are inconclusive.

Every year, 10s of 1000s of patients receive intravenous fluids in the management of bleeding. The Advanced Trauma Life Support (ATLS) protocol of the American College of Surgeons recommends the liberal use of isotonic crystalloid to correct hypotension in bleeding trauma patients. Nevertheless, we could find no reliable evidence to support or not to support this recommendation. While we cannot exclude the possibility that we overlooked a large high‐quality randomised controlled trial showing that early or larger volume fluid resuscitation is beneficial, we believe that this is unlikely. To identify eligible trials we screened over 6000 potentially relevant reports, searched the reference lists of included trials, and contacted authors and experts in the field.

Six published trials were reviewed. Due to their heterogeneity in terms of types of patients and types of fluids used, we did not attempt to perform a meta‐analysis of the studies.

Death was chosen as the primary endpoint in this review for two reasons. First, death is a clinically relevant outcome that matters to patients. Second, death is not prone to measurement error or to reporting bias as are pathophysiological endpoints. Mortality data were available for all six included trials, three on the effect of early fluid resuscitation (Bickell 1994; Blair 1986; Turner 2000) and three on the effect of larger volume fluid resuscitation (Dunham 1991; Dutton 2002; Fortune 1987). Three trials examined the effect of fluid administration on coagulation. Clotting times were significantly elevated in the immediate resuscitation groups (Bickell 1994; Blair 1986) and the group who received a larger volume (Dunham 1991). The method of randomisation was inadequate in two trials (Bickell 1994; Turner 2000) and unclear in another (Dunham 1991). Allocation concealment was inadequate in two trials (Bickell 1994; Turner 2000). Because inadequate randomisation and poorly concealed allocation can bias the results of randomised controlled trials, and because this bias can be large and can operate in either direction, the impact of early or larger volume fluid resuscitation on mortality remains difficult to estimate.

Interpretation of results also needs to be made cautiously due to the heterogeneous nature of the traumatic injuries encountered in these trials. Haemorrhagic shock can be caused by a variety of underlying anatomic injuries. Some of these injuries, such as posterior pelvic fractures, may be more amenable to hypotensive management maintained by a smaller volume of fluid than liver injuries where haemostasis can be difficult to achieve (Dutton 2002).

The use of medical anti‐shock trousers, early and larger volume fluid administration and colloid resuscitation are based on the idea that raising the blood pressure in bleeding trauma patients will maintain tissue perfusion and so prevent haemorrhagic shock and its consequences. However, while maintaining blood pressure may prevent shock, it may worsen bleeding. In view of the lack of evidence for or against the effectiveness of currently recommended resuscitation protocols and the potential for harm, the balance of risks and benefits of contemporary resuscitation practice warrants careful consideration. Further randomised controlled trials are required to identify the most effective strategies for the fluid management of bleeding trauma patients.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.