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Cochrane Database of Systematic Reviews

Profilaxis con levosimendán para la prevención del síndrome de gasto cardíaco bajo y la mortalidad en pacientes pediátricos sometidos a cirugía por una cardiopatía congénita

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Information

DOI:
https://doi.org/10.1002/14651858.CD011312.pub2Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 06 March 2017see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Heart Group

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Johanna Hummel

    Correspondence to: Department of Congenital Heart Defects and Pediatric Cardiology, Heart Center, University of Freiburg, Freiburg, Germany

    [email protected]

    [email protected]

  • Gerta Rücker

    Institute for Medical Biometry and Statistics, Faculty of Medicine and Medical Center – University of Freiburg, Freiburg, Germany

  • Brigitte Stiller

    Department of Congenital Heart Defects and Pediatric Cardiology, Heart Center, University of Freiburg, Freiburg, Germany

Contributions of authors

JH, BS and GR: conceived and designed the review.

JH and BS: collected, screened, extracted, and interpreted data.

JH: co‐ordinated the review, wrote authors for additional data, wrote the protocol and the review.

BS: revised the review critically for important intellectual content.

GR: provided methodological input, analysed data, revised the review critically for important intellectual content.

All authors read and approved the final version of the review.

Sources of support

Internal sources

  • Department of Congenital Heart Defects and Pediatric Cardiology, Heart Center, University of Freiburg, Freiburg, Germany.

    Consists of providing free access to computers, data bases, full‐text literature, collaboration with experts of different faculties and partial release from clinical work to the authors. No additional financial grants.

External sources

  • No sources of support supplied

Declarations of interest

JH: None known.

GR: received payment for a one‐day course on statistical methods in meta‐analysis by Grünenthal Group, Aachen, Germany.

BS: None known.

Acknowledgements

We thank Nicole Martin for her valuable help with the design of the search strategy and the electronic literature searches across databases, as well as her helpful editorial comments. We would also like to thank the authors of the included studies who provided additional data about their trials.

Version history

Published

Title

Stage

Authors

Version

2017 Aug 02

Prophylactic levosimendan for the prevention of low cardiac output syndrome and mortality in paediatric patients undergoing surgery for congenital heart disease

Review

Johanna Hummel, Gerta Rücker, Brigitte Stiller

https://doi.org/10.1002/14651858.CD011312.pub3

2017 Mar 06

Prophylactic levosimendan for the prevention of low cardiac output syndrome and mortality in paediatric patients undergoing surgery for congenital heart disease

Review

Johanna Hummel, Gerta Rücker, Brigitte Stiller

https://doi.org/10.1002/14651858.CD011312.pub2

2014 Sep 25

Prophylactic levosimendan for the prevention of low cardiac output syndrome and mortality in children undergoing surgery for congenital heart disease

Protocol

Johanna Hummel, Gerta Rücker, Brigitte Stiller

https://doi.org/10.1002/14651858.CD011312

Differences between protocol and review

'Children' was replaced by 'paediatric patients' in the review title, since neonates were a relevant part of the included study population.

Definitions of LCOS in the included studies varied and did not necessarily meet the definition stated in the protocol.

The data extraction form that was used was not piloted as mentioned in the protocol, as the number of included studies was very small. We returned to the reports that had already undergone data extraction whenever data were missing from the data extraction form.

Subgroup analyses, as mentioned in the protocol (age‐based and cardiovascular‐physiology‐based), were not feasible due to the small number of events.

In addition to the planned methods stated in the protocol, we provided a ‘Summary of findings’ table in the review to present the main findings in a transparent and simple tabular format. In addition, we conducted a GRADE assessment of the quality of evidence which we also presented in the ‘Summary of findings’ table.

Keywords

MeSH

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
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.
Figures and Tables -
Figure 3

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

Forest plot of comparison: 1 Mortality, outcome: 1.1 Mortality.
Figures and Tables -
Figure 4

Forest plot of comparison: 1 Mortality, outcome: 1.1 Mortality.

Forest plot of comparison: 2 Low cardiac output syndrome (LCOS), outcome: 2.1 LCOS.
Figures and Tables -
Figure 5

Forest plot of comparison: 2 Low cardiac output syndrome (LCOS), outcome: 2.1 LCOS.

Comparison 1 Mortality, Outcome 1 Mortality.
Figures and Tables -
Analysis 1.1

Comparison 1 Mortality, Outcome 1 Mortality.

Comparison 2 Low cardiac output syndrome (LCOS), Outcome 1 LCOS.
Figures and Tables -
Analysis 2.1

Comparison 2 Low cardiac output syndrome (LCOS), Outcome 1 LCOS.

Comparison 3 Length of ICU stay, Outcome 1 Length of ICU stay (days).
Figures and Tables -
Analysis 3.1

Comparison 3 Length of ICU stay, Outcome 1 Length of ICU stay (days).

Comparison 3 Length of ICU stay, Outcome 2 Length of ICU stay (days).
Figures and Tables -
Analysis 3.2

Comparison 3 Length of ICU stay, Outcome 2 Length of ICU stay (days).

Comparison 4 Length of hospital stay, Outcome 1 Length of hospital stay (days).
Figures and Tables -
Analysis 4.1

Comparison 4 Length of hospital stay, Outcome 1 Length of hospital stay (days).

Comparison 5 Duration of mechanical ventilation, Outcome 1 Duration of mechanical ventilation (days).
Figures and Tables -
Analysis 5.1

Comparison 5 Duration of mechanical ventilation, Outcome 1 Duration of mechanical ventilation (days).

Comparison 5 Duration of mechanical ventilation, Outcome 2 Duration of mechanical ventilation (days).
Figures and Tables -
Analysis 5.2

Comparison 5 Duration of mechanical ventilation, Outcome 2 Duration of mechanical ventilation (days).

Comparison 6 Mechanical circulatory support or cardiac transplantation, Outcome 1 Mechanical circulatory support or cardiac transplantation.
Figures and Tables -
Analysis 6.1

Comparison 6 Mechanical circulatory support or cardiac transplantation, Outcome 1 Mechanical circulatory support or cardiac transplantation.

Summary of findings for the main comparison. Prophylactic levosimendan compared to standard treatment in children having undergone heart surgery

Prophylactic levosimendan compared to standard treatment in children following heart surgery

Patient or population: paediatric patients following heart surgery
Setting: institutions providing postoperative care after heart surgery for congenital heart disease
Intervention: levosimendan
Comparison: standard inotropes

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with standard inotropes

Risk with levosimendan

Mortality
follow‐up: range 1 day to 6 days

Study population

RR 0.47
(0.12 to 1.82)

123
(3 RCTs)

⊕⊕⊝⊝
LOW 1, 2

57 per 1000

27 per 1000
(7 to 104)

Low cardiac output syndrome (LCOS)
follow‐up: range 1 day to 6 days

Study population

RR 0.64
(0.39 to 1.04)

83
(2 RCTs)

⊕⊕⊝⊝
LOW 1, 3

367 per 1000

235 per 1000
(143 to 381)

Length of intensive care unit stay (Length of ICU stay)
follow‐up: range 1 day to 6 days

The mean length of stay in the ICU in the control groups ranged from 2.05 to 11 days

The mean length of stay in ICU in the intervention groups was 0.33 days higher (1.16 lower to 1.82 higher)

188
(4 RCTs)

⊕⊕⊝⊝
LOW 1, 4

Length of hospital stay
follow‐up: range 1 day to 6 days

The mean length of hospital stay in the control groups ranged from 15 to 15.8 days

The mean length of hospital stay in the intervention groups was 0.26 days higher
(3.50 lower to 4.03 higher)

75
(2 RCTs)

⊕⊕⊝⊝
LOW 1, 2

Duration of mechanical ventilation
follow‐up: range 1 day to 6 days

The mean duration of mechanical ventilation in the control groups ranged from 0.29 to 6.5 days

The mean duration of mechanical ventilation in the intervention groups was 0.04 days lower
(0.08 lower to 0.00 higher)

208
(5 RCTs)

⊕⊕⊝⊝
LOW 1, 4

Mechanical circulatory support or cardiac transplantation
follow‐up: range 1 day to 6 days

Study population

RR 1.49
(0.19 to 11.37)

60
(2 RCTs)

⊕⊕⊝⊝
LOW 1, 2

10 per 1000

14 per 1000
(2 to 108)

*The risk in the intervention group (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; OR: Odds ratio; MD: mean difference.

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Downgraded for imprecision due to small sample size.

2 Downgraded for imprecision due to few number of events (less than 300).

3 Detection of outcome potentially dependent on study personnel: risk of detection bias in two studies due to unblinded setting.

4 Considerable inconsistency between study results.

Figures and Tables -
Summary of findings for the main comparison. Prophylactic levosimendan compared to standard treatment in children having undergone heart surgery
Comparison 1. Mortality

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

3

123

Risk Ratio (M‐H, Random, 95% CI)

0.47 [0.12, 1.82]

Figures and Tables -
Comparison 1. Mortality
Comparison 2. Low cardiac output syndrome (LCOS)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 LCOS Show forest plot

2

83

Risk Ratio (M‐H, Random, 95% CI)

0.64 [0.39, 1.04]

Figures and Tables -
Comparison 2. Low cardiac output syndrome (LCOS)
Comparison 3. Length of ICU stay

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Length of ICU stay (days) Show forest plot

4

188

Mean Difference (IV, Random, 95% CI)

0.33 [‐1.16, 1.82]

2 Length of ICU stay (days) Show forest plot

4

188

Std. Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.54, 0.44]

Figures and Tables -
Comparison 3. Length of ICU stay
Comparison 4. Length of hospital stay

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Length of hospital stay (days) Show forest plot

2

75

Mean Difference (IV, Random, 95% CI)

0.26 [‐3.50, 4.03]

Figures and Tables -
Comparison 4. Length of hospital stay
Comparison 5. Duration of mechanical ventilation

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Duration of mechanical ventilation (days) Show forest plot

5

208

Mean Difference (IV, Random, 95% CI)

‐0.04 [‐0.08, 0.00]

2 Duration of mechanical ventilation (days) Show forest plot

5

208

Std. Mean Difference (IV, Random, 95% CI)

‐0.08 [‐0.43, 0.27]

Figures and Tables -
Comparison 5. Duration of mechanical ventilation
Comparison 6. Mechanical circulatory support or cardiac transplantation

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mechanical circulatory support or cardiac transplantation Show forest plot

2

60

Risk Ratio (M‐H, Random, 95% CI)

1.49 [0.19, 11.37]

Figures and Tables -
Comparison 6. Mechanical circulatory support or cardiac transplantation