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Comparison · NCT03229538-1eddeb12

Methylprednisolone Arm vs Placebo Arm: Number of Participants With Post-operative Low Cardiac Output Syndrome

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Methylprednisolone Arm vs Placebo Arm: Number of Participants With Post-operative Low Cardiac Output Syndrome. Trial comparisons, record NCT03229538-1eddeb12. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03229538-1eddeb12

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.05180.03670.0725wilson
Risk in group 20.06160.0450.0837wilson
Risk difference, group 1 minus group 2-0.00981-0.03660.0168newcombe hybrid score
Risk ratio, group 1 over group 20.8410.5291.34log
Odds ratio, group 1 over group 20.8320.5091.36log
Number needed to treat, for one fewer participant with the outcome on Methylprednisolone Arm than on Placebo Arm102from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Methylprednisolone ArmIV Methylprednisolone~Methylprednisolone: IV Steroid pre-operative and intra-operative31599OG000
Group 2Placebo ArmIV Isotonic Saline~Isotonic saline: Isotonic saline pre-operative and intra-operative37601OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Post-operative Low Cardiac Output Syndrome
Description
Based upon the STS-CHSD registry defined cardiac dysfunction resulting in low cardiac output complication variable.
Time frame
Until hospital discharge, up to 4 months
Population

Source ClinicalTrials.gov

Trial

Title
STeroids to REduce Systemic Inflammation After Infant Heart Surgery
NCT number
NCT03229538
Phases
PHASE3
Conditions
Congenital Heart Disease in Children, Inflammatory Response
Interventions
Methylprednisolone, Isotonic saline
Lead sponsor
Kevin Hill
Results first posted
2023-05-10

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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