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Cardioplegia in paediatric cardiac surgery: a systematic review of randomized controlled trials
Nigel E Drury1,2, Ivan Yim1, Akshay J Patel1
1Department of Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, UK.
Insights
This systematic review found limited evidence on cardioplegia for myocardial protection in pediatric cardiac surgery due to small, low-quality trials. Developing a core outcome set is crucial for future high-quality research in pediatric cardioplegia.
Area of Science:
- Pediatric Cardiac Surgery
- Cardiovascular Research
- Evidence-Based Medicine
Background:
- Cardioplegia is essential for protecting the heart muscle during cardiac surgery.
- Evaluating the existing evidence on cardioplegia in pediatric patients is critical for improving surgical outcomes.
- A systematic review was conducted to assess the quality and scope of randomized controlled trials (RCTs) concerning cardioplegia in children.
Purpose of the Study:
- To systematically review and evaluate the current evidence base of randomized controlled trials (RCTs) on cardioplegia for myocardial protection in pediatric cardiac surgery.
- To identify the types of cardioplegia solutions and additives studied in children.
- To assess the quality and limitations of existing research.
Main Methods:
- A comprehensive search of MEDLINE, CENTRAL, and LILACS databases was performed.
- Included were RCTs comparing cardioplegia solutions or additives in pediatric cardiac surgery patients; excluded were secondary publications and studies with inseparable adult data.
- Data extraction and risk of bias assessment using the Cochrane Risk of Bias tool were conducted independently by at least two reviewers.
Main Results:
- Twenty-six trials involving 1596 children were identified, all single-center Phase II trials with small patient numbers.
- The most common comparisons involved blood versus crystalloid cardioplegia.
- Frequent outcome measures included biomarkers of myocardial injury, inotrope requirements, and intensive care unit length of stay, but heterogeneity precluded meta-analysis.
Conclusions:
- The current literature on pediatric cardioplegia lacks late-phase trials and is characterized by small sample sizes, inconsistent endpoints, and low methodological quality.
- The limited evidence base necessitates the development of a core outcome set for standardized, validated endpoints.
- High-quality, multicenter trials are needed to establish best practices for myocardial protection in pediatric cardiac surgery.
Objectives:
Cardioplegia is the primary method for myocardial protection during cardiac surgery. We conducted a systematic review of randomized controlled trials of cardioplegia in children to evaluate the current evidence base.
Methods:
We searched MEDLINE, CENTRAL and LILACS and manually screened retrieved references and systematic reviews to identify all randomized controlled trials comparing cardioplegia solutions or additives in children undergoing cardiac surgery published in any language; secondary publications and those reporting inseparable adult data were excluded. Two or more reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases.
Results:
We identified 26 trials randomizing 1596 children undergoing surgery; all were single-centre, Phase II trials, recruiting few patients (median 48, interquartile range 30-99). The most frequent comparison was blood versus crystalloid in 10 (38.5%) trials, and the most common end points were biomarkers of myocardial injury (17, 65.4%), inotrope requirements (15, 57.7%) and length of stay in the intensive care unit (11, 42.3%). However, the heterogeneity of patients, interventions and reported outcome measures prohibited meta-analysis. Overall risk of bias was high in 3 (11.5%) trials, unclear in 23 (88.5%) and low in none.
Conclusions:
The current literature on cardioplegia in children contains no late phase trials. The small size, inconsistent use of end points and low quality of reported trials provide a limited evidence base to inform practice. A core outcome set of clinically important, standardized, validated end points for assessing myocardial protection in children should be developed to facilitate the conduct of high-quality, multicentre trials.
Prospero Registration:
CRD42017080205.
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