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Cochrane Database of Systematic Reviews

Optimisation du volume de fluides périopératoire après fracture du fémur proximal

Información

DOI:
https://doi.org/10.1002/14651858.CD003004.pub4Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 14 marzo 2016see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Anestesia

Copyright:
  1. Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

  • Sharon R Lewis

    Patient Safety Research, Royal Lancaster Infirmary, Lancaster, UK

  • Andrew R Butler

    Research Department, University Hospitals of Morecambe Bay NHS Foundation Trust, Lancaster, UK

  • Andrew Brammar

    Department of Anaesthesia, University Hospital of South Manchester, Manchester, UK

  • Amanda Nicholson

    Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, UK

  • Andrew F Smith

    Correspondencia a: Department of Anaesthesia, Royal Lancaster Infirmary, Lancaster, UK

    [email protected]

Contributions of authors

Andrew F Smith (AFS) identified the need for the review update.

Sharon R Lewis (SRL) and Andrew R Butler (ARB) performed the initial searches, applied inclusion criteria and extracted study data.

SRL and ARB compiled the results.

SRL drafted the review.

All review authors reviewed and refined the final manuscript.

Sources of support

Internal sources

  • Oxford Radcliffe Hospitals NHS Trust, UK.

External sources

  • NIHR Cochrane Collaboration Programme Grant, UK.

    • NIHR Cochrane Collaboration Programme Grant. Enhancing the safety, quality and productivity of perioperative care. Project Ref: 10/4001/04, UK. This grant funds the work of AN and AFS on this review.

Declarations of interest

Andrew Brammar: none known.

Andrew F Smith: none known.

Sharon R Lewis: none known

Andrew R Butler: none known.

Amanda Nicholson (AN): From June 2015, AN has worked for Q Medical Technology Limited, a firm that markets and distributes a range of medical devices. AN made no substantial contribution to the review while working at Q Medical Technologies Limited. None of the company's products are directly relevant to the subject of this review. AN's husband has small direct holdings in several drug and biotech companies as part of a wider balanced share portfolio.

Acknowledgements

We would like to thank Stephan Kettner (Content Editor), Cathal Walsh (Statistical Editor) and Sheila Page (Consumer Reviewer) for help and editorial advice provided during preparation of this updated systematic review.

We also would like to thank Dr Craig Goldsack, Dr Dominik Krzanicki and Dr Jonathan Pimm for their contributions in reshaping the original review to the new review format before it was updated (Brammar 2013), and we would like to thank previous Consumer Editor Robert Wylie.

We would like to acknowledge the work of Dr James Price, Dr John Sear and Dr Richard Venn, who authored the first review (Price 2004).

Version history

Published

Title

Stage

Authors

Version

2016 Mar 14

Perioperative fluid volume optimization following proximal femoral fracture

Review

Sharon R Lewis, Andrew R Butler, Andrew Brammar, Amanda Nicholson, Andrew F Smith

https://doi.org/10.1002/14651858.CD003004.pub4

2013 Sep 11

Perioperative fluid volume optimization following proximal femoral fracture

Review

Andrew Brammar, Amanda Nicholson, Marialena Trivella, Andrew F Smith

https://doi.org/10.1002/14651858.CD003004.pub3

2004 Jan 26

Perioperative fluid volume optimization following proximal femoral fracture

Review

James D Price, John JW Sear, Richard RM Venn

https://doi.org/10.1002/14651858.CD003004.pub2

2000 Dec 28

Perioperative fluid volume optimization following proximal femoral fracture

Review

James D Price, John JW Sear, Richard RM Venn

https://doi.org/10.1002/14651858.CD003004

Differences between protocol and review

Alterations made in earlier review (Brammar 2013)

We altered and re‐ran the search strategy using updated key terms from inception of the databases to October 2012. In addition to CENTRAL, MEDLINE and EMBASE, we searched the International Clinical Trials Registry Platform and ClinicalTrials.gov websites for ongoing and unpublished studies (see Appendix 1; Appendix 2; Appendix 3; Appendix 4; Appendix 5). We carried out backward and forward citation searching for key review articles identified during the initial searches (see Appendix 6). We repeated title selection and full‐text review in full.

We moved one study from excluded to included studies (Schultz 1985). We added one study as awaiting classification pending contact with study authors (Sandham 2003). We added two ongoing studies (GDHT study; NOTTS study).

We used the Cochrane 'Risk of bias' tool to assess the quality of studies. We did not exclude studies on the basis of low quality.

We altered comparison groups so that protocol measures and advanced haemodynamic methods were compared with each other and were not combined.

We redefined outcomes to separate length of stay into time to medical fitness and total stay. The all‐cause mortality time frame was changed to include in‐hospital, 30 days and undefined. We changed reduced return of function outcomes to time to the pre‐fracture category of accommodation and mobility. We re‐classified complications into major iatrogenic, cardiopulmonary, neurological and combined, including minor.

We included 'Summary of findings' tables for all comparisons, using the principles of the GRADE (Grades of Recommendation, Assessment, Development and Evaluation Working Group) system (Guyatt 2008) to assess the quality of the body of evidence associated with specific outcomes.

Keywords

MeSH

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.

Study flow diagram. Updated search October 2012 to January 2015.
Figuras y tablas -
Figure 1

Study flow diagram. Updated search October 2012 to January 2015.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Advanced haemodynamic monitoring versus protocol using standard measures, Outcome 1 All‐cause mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 Advanced haemodynamic monitoring versus protocol using standard measures, Outcome 1 All‐cause mortality.

Comparison 1 Advanced haemodynamic monitoring versus protocol using standard measures, Outcome 2 Adverse outcomes.
Figuras y tablas -
Analysis 1.2

Comparison 1 Advanced haemodynamic monitoring versus protocol using standard measures, Outcome 2 Adverse outcomes.

Comparison 2 Advanced haemodynamic monitoring versus usual care, Outcome 1 All‐cause mortality.
Figuras y tablas -
Analysis 2.1

Comparison 2 Advanced haemodynamic monitoring versus usual care, Outcome 1 All‐cause mortality.

Comparison 2 Advanced haemodynamic monitoring versus usual care, Outcome 2 Total length of hospital stay.
Figuras y tablas -
Analysis 2.2

Comparison 2 Advanced haemodynamic monitoring versus usual care, Outcome 2 Total length of hospital stay.

Comparison 2 Advanced haemodynamic monitoring versus usual care, Outcome 3 Days until medically fit for discharge.
Figuras y tablas -
Analysis 2.3

Comparison 2 Advanced haemodynamic monitoring versus usual care, Outcome 3 Days until medically fit for discharge.

Comparison 2 Advanced haemodynamic monitoring versus usual care, Outcome 4 Adverse outcomes.
Figuras y tablas -
Analysis 2.4

Comparison 2 Advanced haemodynamic monitoring versus usual care, Outcome 4 Adverse outcomes.

Summary of findings for the main comparison. Advanced haemodynamic monitoring compared with protocol using standard measures such as CVP for proximal femoral fracture

Advanced haemodynamic monitoring compared with protocol using standard measures such as CVP for proximal femoral fracture

Patient or population: patients with proximal femoral fracture
Setting: hospital
Intervention: advanced haemodynamic monitoring
Comparison: protocol using standard measures such as CVP

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Protocol using standard measures such as CVP

Advanced haemodynamic monitoring

All‐cause mortality
Advanced haemodynamic monitoring
Follow‐up: 30 days

Study population

RR 0.41
(0.14 to 1.2)

280
(3 studies)

⊕⊝⊝⊝
Very lowa,b,c

142 per 1000

58 per 1000
(20 to 170)

Moderate

Total length of hospital stay

Not estimabled

203
(2 studies)

⊕⊕⊝⊝
Lowc,d

Data reported as median (range) in Bartha 2013 and as mean (95% confidence interval) in Venn 2002

Medically fit for discharge

Mean medically fit for discharge in the intervention groups was
7.7 higher
(5.9 to 0 higher)

90
(1 study)

⊕⊕⊝⊝
Lowe

Return to pre‐fracture accommodation/return to pre‐fracture mobility

Not estimable

Not reported

Adverse outcomes ‐ cardiopulmonary

Study population

Not estimable

0
(0)

Moderate

Adverse outcomes ‐ neurological

Not estimable

0
(0)

Adverse outcomes ‐ all

Study population

RR 0.90
(0.37 to 2.18)

280
(3 studies)

⊕⊝⊝⊝
Very lowa,b,c

319 per 1000

287 per 1000
(118 to 696)

Moderate

*The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
CI: confidence interval; CVP: central venous pressure; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very low quality: We are very uncertain about the estimate.

aConcerns about randomization process in Schultz 1985; high risk of selection bias
bConfidence intervals cross no effect and are consistent with increased as well as decreased risk. Downgraded 1 level
cEstimate from few studies or from 1 study only. Downgraded 1 level
dNot possible to combine data. Wide confidence interval in Venn 2002 and wide range reported in Bartha 2013. Downgraded 1 level

eData from 1 study only. Downgraded 2 levels

Figuras y tablas -
Summary of findings for the main comparison. Advanced haemodynamic monitoring compared with protocol using standard measures such as CVP for proximal femoral fracture
Summary of findings 2. Advanced haemodynamic monitoring compared with usual care for perioperative fluid optimization

Advanced haemodynamic monitoring compared with usual care for perioperative fluid optimization

Patient or population: patients with perioperative fluid optimization
Settings: hospital
Intervention: advanced haemodynamic monitoring
Comparison: usual care

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Usual care

Advanced haemodynamic monitoring

All‐cause mortality

Study population

RR 0.45
(0.07 to 2.95)

213
(3 studies)

⊕⊕⊝⊝
Lowa,b

89 per 1000

40 per 1000
(6 to 263)

Moderate

Total length of hospital stay

Mean total length of hospital stay in the control groups was
number of days

Mean total length of hospital stay in the intervention groups was
0.63 higher
(1.7 lower to 2.96 higher)

175
(2 studiesc)

⊕⊕⊝⊝
Lowa,b

Medically fit for discharge

Mean medically fit for discharge in the control groups was
number of days

Mean medically fit for discharge in the intervention groups was
0.01 higher
(1.74 lower to 1.71 higher)

175
(2 studiesd)

⊕⊕⊝⊝
Lowa,b

Return to pre‐fracture accommodation/return to pre‐fracture mobility

Study population

Not estimable

114
(1 study)

⊕⊕⊝⊝
Lowb

397 per 1000

0 per 1000
(0 to 0)

Moderate

Adverse outcomes ‐ cardiopulmonary

Study population

Not estimable

0
(0)

Moderate

Adverse outcomes ‐ neurological

Study population

RR 1.10
(0.56 to 2.18)

173
(2 studies)

⊕⊕⊝⊝
Lowa,b

152 per 1000

170 per 1000
(1000 to 336)

Moderate

Adverse outcomes ‐ all

Study population

RR 0.78
(0.57 to 1.05)

173
(2 studies)

⊕⊕⊝⊝
Lowa,b

554 per 1000

432 per 1000
(316 to 582)

Moderate

*The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
CI: confidence interval; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very low quality: We are very uncertain about the estimate

aConfidence intervals cross no effect and are consistent with increased as well as decreased risk. Downgraded 1 level
bEstimate from only 1 or a few studies. Downgraded 1 level
cData for Sinclair 1997 not included in meta‐analysis. Study authors report a reduction of 8 days in total hospital stay (from 20 to 12) in the advanced haemodynamic group (P value < 0.05)
dData for Sinclair 1997 not included in meta‐analysis. Study authors report a reduction of 5 days in median time to fitness for discharge (from 15 to 10 days)

Figuras y tablas -
Summary of findings 2. Advanced haemodynamic monitoring compared with usual care for perioperative fluid optimization
Summary of findings 3. Protocol using standard measures such as CVP compared with usual care for perioperative fluid optimization

Protocol using standard measures such as CVP compared with usual care for perioperative fluid optimization

Patient or population: patients with perioperative fluid optimization
Setting: hospital
Intervention: protocol using standard measures such as CVP
Comparison: usual care

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Usual care

Protocol using standard measures such as CVP

All‐cause mortality

Study population

RR 2.81
(0.61 to 12.81)

60
(1 study)

⊕⊕⊝⊝
Lowa,b

69 per 1000

194 per 1000
(42 to 883)

Moderate

Total length of hospital stay

Mean total length of hospital stay in the control groups was
4.2 days

Mean total length of hospital stay in the intervention groups was
4.20 lower
(11.0 lower to 2.6 higher)

60
(1 study)

⊕⊕⊝⊝
Lowa,b

Medically fit for discharge

Mean medically fit for discharge in the intervention groups was
3.90 lower
(7.05 to 0.75 lower)

60
(1 study)

⊕⊕⊕⊝
Moderateb

Return to pre‐fracture accommodation/return to pre‐fracture mobility

Not estimable

Not reported

Adverse outcomes ‐ cardiopulmonary

Study population

Not estimable

0
(0)

Not reported

Moderate

Adverse outcomes ‐ neurological

Study population

RR 0.94
(0.06 to 14.27)

60
(1 study)

⊕⊕⊝⊝
Low

34 per 1000

32 per 1000
(2 to 492)

Moderate

Adverse outcomes ‐ all

Study population

RR 0.53
(0.26 to 1.08)

60
(1 study)

⊕⊕⊝⊝
Lowa,b

483 per 1000

256 per 1000
(126 to 521)

Moderate

*The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
CI: confidence interval; CVP: central venous pressure; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very low quality: We are very uncertain about the estimate

aBased on 1 study with a small number of events. Wide confidence intervals consistent with increased as well as decreased risk. Downgraded by 1 level
bBased on 1 study with a small number of participants. Downgraded by 1 level

Figuras y tablas -
Summary of findings 3. Protocol using standard measures such as CVP compared with usual care for perioperative fluid optimization
Table 1. Adverse events. Comparison 1. Advanced haemodynamic monitoring versus protocol using standard measures

Study ID

Adverse events

Advanced haemodynamic monitoring

Protocol using standard measures

Bartha 2013

n = 74

n = 75

Cardiopulmonary

Cardiovascular 5

Respiratory 5

Cardiovascular 6

Respiratory 7

Neurological

Cerebrovascular 0

Confusion 3

Cerebrovascular 2

Confusion 6

Other

Acute kidney failure 1

Gastrointestinal bleeding 0

Sepsis 2

Deep vein thrombosis 0

Wound infection 2

Delayed healing 0

Urinary tract infection 16

Decubitus 6

Wound haematoma 0

Other 4

Acute kidney failure 1

Gastrointestinal bleeding 0

Sepsis 0

Deep vein thrombosis 0

Wound infection 1

Delayed healing 0

Urinary tract infection 12

Decubitus 1

Wound haematoma 1

Other 6

Schultz 1985

n = 35

n = 35

Other

Pneumonia 1

Wound infection 1

Pneumonitis 1

Pneumonia 2

Decubitis ulcer 1

Venn 2002

n = 30

n = 31

Cardiopulmonary

Chest infection 2

Pulmonary embolus 1

Myocardial infarction 0

Cardiac failure 0

Rapid atrial fibrillation 3

Hypotension 0

Chest infection 3

Pulmonary embolus 0

Myocardial infarction 1

Cardiac failure 1

Rapid atrial fibrillation 1

Hypotension 0

Neurological

Cerebrovascular accident 2

Cerebrovascular accident 1

Other

Deep haemorrhage 1

Haematemesis 0

Wound infection 0

Urinary tract infection 2

Cellulitis 0

Pancreatitis 0

Hypotension 0

Impaired renal function 0

Pseudo‐obstruction 0

Deep haemorrhage 0

Haematemesis 0

Wound infection 0

Urinary tract infection 1

Cellulitis 1

Pancreatitis 0

Hypotension 0

Impaired renal function 0

Pseudo‐obstruction 1

Figuras y tablas -
Table 1. Adverse events. Comparison 1. Advanced haemodynamic monitoring versus protocol using standard measures
Table 2. Adverse events. Comparison 2. Advanced haemodynamic monitoring versus usual care

Study ID

Adverse events

Advanced haemodynamic monitoring

Usual care

Moppett 2014

n = 51

n = 63

Cardiopulmonary

Cardiovascular 8

Respiratory 0

Cardiovascular 6

Respiratory 0

Neurological

Acute delirium 11

Acute delirium 13

Other

Infectious 21

Abdominal 2

Bleeding 0

Skin 0

Renal (RIFLE) 18*

Other 3

Infectious 34

Abdominal 1

Bleeding 0

Skin 0

Renal (RIFLE) 32*

Other 3

Venn 2002

n = 30

n = 29

Cardiopulmonary

Chest infection 2

Pulmonary embolus 1

Myocardial infarction 0

Cardiac failure 0

Rapid atrial fibrillation 3

Hypotension 0

Chest infection 5

Pulmonary embolus 0

Myocardial infarction 0

Cardiac failure 0

Rapid atrial fibrillation 2

Hypotension 3

Neurological

Cerebrovascular accident 2

Cerebrovascular accident 1

Other

Deep haemorrhage 1

Haematemesis 0

Wound infection 0

Urinary tract infection 2

Cellulitis 0

Pancreatitis 0

Hypotension 0

Impaired renal function 0

Pseudo‐obstruction 0

Deep haemorrhage 1

Haematemesis 1

Wound infection 2

Urinary tract infection 3

Cellulitis 0

Pancreatitis 1

Hypotension 3

Impaired renal function 2

Pseudo‐obstruction 0

*RIFLE scores sum of patients at risk, injury or failure

Figuras y tablas -
Table 2. Adverse events. Comparison 2. Advanced haemodynamic monitoring versus usual care
Table 3. Comparison 3. Protocol using standard measures versus usual care (Venn 2002)

Outcomes reported in

Venn 2002: comparison 3

Protocol ‐

CVP

N = 31

Standard care

 

N = 29

Effect estimate

(95% CI)

 

Mean

SD

Mean

SD

Mean difference

Length of hospital stay (days)

13.3

12.1

17.5

13.8

‐4.20 (‐11.0 to 2.60)

Time to fitness to discharge

10

5.3

13.9

6.6

‐3.90 (‐7.05 to ‐0.75)

 

 

 

 

 

 

 

Events

 

Events

 

MH relative risk

Mortality

6

 

2

 

2.81 (0.61 to 12.81)

Adverse events

 

 

 

 

 

·        Cardiopulmonary ‐ episodes

6

 

7

 

N/A

·        Neurological ‐ participants

1

 

1

 

0.94 (0.06 to 14.27)

·        Any, including minor ‐ participants

8

 

14

 

0.53 (0.26 to 1.08)

Figuras y tablas -
Table 3. Comparison 3. Protocol using standard measures versus usual care (Venn 2002)
Comparison 1. Advanced haemodynamic monitoring versus protocol using standard measures

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 All‐cause mortality Show forest plot

3

280

Risk Ratio (M‐H, Random, 95% CI)

0.41 [0.14, 1.20]

2 Adverse outcomes Show forest plot

3

280

Risk Ratio (M‐H, Random, 95% CI)

0.83 [0.59, 1.17]

2.1 Any complications, including minor

3

280

Risk Ratio (M‐H, Random, 95% CI)

0.83 [0.59, 1.17]

Figuras y tablas -
Comparison 1. Advanced haemodynamic monitoring versus protocol using standard measures
Comparison 2. Advanced haemodynamic monitoring versus usual care

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 All‐cause mortality Show forest plot

3

213

Risk Ratio (M‐H, Random, 95% CI)

0.45 [0.07, 2.95]

2 Total length of hospital stay Show forest plot

2

173

Mean Difference (IV, Fixed, 95% CI)

0.63 [‐1.70, 2.96]

3 Days until medically fit for discharge Show forest plot

2

173

Mean Difference (IV, Fixed, 95% CI)

‐0.01 [‐1.74, 1.71]

4 Adverse outcomes Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

4.1 Neurological

2

173

Risk Ratio (M‐H, Random, 95% CI)

1.10 [0.56, 2.18]

4.2 Any complications, including minor

2

173

Risk Ratio (M‐H, Random, 95% CI)

0.72 [0.40, 1.31]

Figuras y tablas -
Comparison 2. Advanced haemodynamic monitoring versus usual care