Cardiothoracic & vascular anesthesia

Methylprednisolone for Infant Heart Surgery: Subpopulation Analyses of a Randomized Controlled Trial

Crit Care MedPublished Secondary analysis of the STRESS randomised trial

Authors' conclusion

Both beneficial and adverse associations were observed with prophylactic methylprednisolone.

Study context

Population
Infants (< 1 yr old) undergoing heart surgery with CPB, stratified by STAT mortality category, age, gestational age and chromosomal or syndromic diagnosis (CSD)
Participants
1,200 infants
Comparison
Methylprednisolone vs placebo in CPB pump-priming fluid
Primary endpoint
Postoperative outcomes: steroid use, acute kidney injury (AKI), thrombosis, infections, prolonged mechanical ventilation, peak blood glucose levels, and insulin exposure
Methodological detailssubpopulation analyses, double-blind, placebo-controlled, multicentre (24 congenital heart centers)
  • Subpopulation analyses
  • Double-blind
  • Placebo-controlled
  • Multicentre (24 congenital heart centers)

Primary result

As reported in the abstract

Postoperative hydrocortisone use (subgroups)
Methylprednisolone vs PlaceboOdds ratio (CI)
Neonates
0.39(0.25–0.60)
STAT category 1-3
0.64(0.46–0.89)
STAT category 4-5
0.57(0.34–0.97)
Term infants
0.63(0.47–0.83)
Without CSD
0.63(0.46–0.86)

Further findings

OutcomeOR (CI)
Thrombosis (subgroups)Methylprednisolone vs Placebo · neonates0.37 (0.16–0.87)
Thrombosis (subgroups)Methylprednisolone vs Placebo · term infants0.38 (0.19–0.75)

Overall infection and prolonged mechanical ventilation

No increase in overall infection or reduction in prolonged mechanical ventilation with methylprednisolone

Safety

OutcomeOR (CI)
AKI (subgroups)Methylprednisolone vs Placebo · neonates1.55 (1.02–2.37)
AKI (subgroups)Methylprednisolone vs Placebo · STAT category 1-31.34 (1.02–1.75)

Thrombosis, premature infants (subgroup)

Increased thrombosis among premature infants
P = 0.005

Peak blood glucose levels and insulin exposure

Increased in all subgroups
P < 0.001

Original publication

Methylprednisolone for Infant Heart Surgery: Subpopulation Analyses of a Randomized Controlled Trial. Crit Care Med. Published 21 May 2025. doi:10.1097/ccm.0000000000006721

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