Methylprednisolone for Heart Surgery in Infants - A Randomized, Controlled Trial.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
08 12 2022
08 12 2022
Historique:
pubmed:
8
11
2022
medline:
15
12
2022
entrez:
7
11
2022
Statut:
ppublish
Résumé
Although perioperative prophylactic glucocorticoids have been used for decades, whether they improve outcomes in infants after heart surgery with cardiopulmonary bypass is unknown. We conducted a multicenter, prospective, randomized, placebo-controlled, registry-based trial involving infants (<1 year of age) undergoing heart surgery with cardiopulmonary bypass at 24 sites participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database. Registry data were used in the evaluation of outcomes. The infants were randomly assigned to receive prophylactic methylprednisolone (30 mg per kilogram of body weight) or placebo, which was administered into the cardiopulmonary-bypass pump-priming fluid. The primary end point was a ranked composite of death, heart transplantation, or any of 13 major complications. Patients without any of these events were assigned a ranked outcome based on postoperative length of stay. In the primary analysis, the ranked outcomes were compared between the trial groups with the use of odds ratios adjusted for prespecified risk factors. Secondary analyses included an unadjusted odds ratio, a win ratio, and safety outcomes. A total of 1263 infants underwent randomization, of whom 1200 received either methylprednisolone (599 infants) or placebo (601 infants). The likelihood of a worse outcome did not differ significantly between the methylprednisolone group and the placebo group (adjusted odds ratio, 0.86; 95% confidence interval [CI], 0.71 to 1.05; P = 0.14). Secondary analyses (unadjusted for risk factors) showed an odds ratio for a worse outcome of 0.82 (95% CI, 0.67 to 1.00) and a win ratio of 1.15 (95% CI, 1.00 to 1.32) in the methylprednisolone group as compared with the placebo group, findings suggestive of a benefit with methylprednisolone; however, patients in the methylprednisolone group were more likely than those in the placebo group to receive postoperative insulin for hyperglycemia (19.0% vs. 6.7%, P<0.001). Among infants undergoing surgery with cardiopulmonary bypass, prophylactic use of methylprednisolone did not significantly reduce the likelihood of a worse outcome in an adjusted analysis and was associated with postoperative development of hyperglycemia warranting insulin in a higher percentage of infants than placebo. (Funded by the National Center for Advancing Translational Sciences and others; STRESS ClinicalTrials.gov number, NCT03229538.).
Sections du résumé
BACKGROUND
Although perioperative prophylactic glucocorticoids have been used for decades, whether they improve outcomes in infants after heart surgery with cardiopulmonary bypass is unknown.
METHODS
We conducted a multicenter, prospective, randomized, placebo-controlled, registry-based trial involving infants (<1 year of age) undergoing heart surgery with cardiopulmonary bypass at 24 sites participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database. Registry data were used in the evaluation of outcomes. The infants were randomly assigned to receive prophylactic methylprednisolone (30 mg per kilogram of body weight) or placebo, which was administered into the cardiopulmonary-bypass pump-priming fluid. The primary end point was a ranked composite of death, heart transplantation, or any of 13 major complications. Patients without any of these events were assigned a ranked outcome based on postoperative length of stay. In the primary analysis, the ranked outcomes were compared between the trial groups with the use of odds ratios adjusted for prespecified risk factors. Secondary analyses included an unadjusted odds ratio, a win ratio, and safety outcomes.
RESULTS
A total of 1263 infants underwent randomization, of whom 1200 received either methylprednisolone (599 infants) or placebo (601 infants). The likelihood of a worse outcome did not differ significantly between the methylprednisolone group and the placebo group (adjusted odds ratio, 0.86; 95% confidence interval [CI], 0.71 to 1.05; P = 0.14). Secondary analyses (unadjusted for risk factors) showed an odds ratio for a worse outcome of 0.82 (95% CI, 0.67 to 1.00) and a win ratio of 1.15 (95% CI, 1.00 to 1.32) in the methylprednisolone group as compared with the placebo group, findings suggestive of a benefit with methylprednisolone; however, patients in the methylprednisolone group were more likely than those in the placebo group to receive postoperative insulin for hyperglycemia (19.0% vs. 6.7%, P<0.001).
CONCLUSIONS
Among infants undergoing surgery with cardiopulmonary bypass, prophylactic use of methylprednisolone did not significantly reduce the likelihood of a worse outcome in an adjusted analysis and was associated with postoperative development of hyperglycemia warranting insulin in a higher percentage of infants than placebo. (Funded by the National Center for Advancing Translational Sciences and others; STRESS ClinicalTrials.gov number, NCT03229538.).
Identifiants
pubmed: 36342116
doi: 10.1056/NEJMoa2212667
pmc: PMC9843240
mid: NIHMS1861125
doi:
Substances chimiques
Methylprednisolone
X4W7ZR7023
Insulin
0
Banques de données
ClinicalTrials.gov
['NCT03229538']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
2138-2149Subventions
Organisme : NHLBI NIH HHS
ID : RC1 HL099941
Pays : United States
Organisme : NCATS NIH HHS
ID : 1U01TR001803-01
Pays : United States
Organisme : NCATS NIH HHS
ID : U24 TR001608
Pays : United States
Organisme : NICHD NIH HHS
ID : K23 HD061601
Pays : United States
Organisme : NHLBI NIH HHS
ID : K08 HL116639
Pays : United States
Organisme : CSRD VA
ID : IK2 CX001717
Pays : United States
Organisme : NCATS NIH HHS
ID : U01 TR001803
Pays : United States
Organisme : NCATS NIH HHS
ID : U24TR-001608-03
Pays : United States
Organisme : NIAID NIH HHS
ID : K01 AI073729
Pays : United States
Organisme : NICHD NIH HHS
ID : HHSN267200700051C
Pays : United States
Investigateurs
Venugopal Amula
(V)
Nick Andersen
(N)
Jean Ballweg
(J)
Scott M Bradley
(SM)
Jason R Buckley
(JR)
Reid C Chamberlain
(RC)
Karla G Christian
(KG)
John D Cleveland
(JD)
Nhue Do
(N)
Will Gibson
(W)
Christoph P Hornik
(CP)
James Jaggers
(J)
Minoo N Kavarana
(MN)
William Ravekes
(W)
Jennifer Schuette
(J)
Sarah Tabutt
(S)
Richard V Williams
(RV)
Sinai C Zyblewski
(SC)
Timothy F Feltes
(TF)
Matthew Laughon
(M)
Kimberlee Gauvreau
(K)
Jane Newburger
(J)
Eric Graham
(E)
James Tweddel
(J)
Lori Smoot
(L)
Soju Chang
(S)
Sergei Avdiushko
(S)
Susan Bartone
(S)
Gail Beaulieu
(G)
Darwin Chavez
(D)
Stephanie Decker
(S)
Deborah Drosdick
(D)
Laura Edwards
(L)
Carrie Elliott
(C)
Alicia Ellis
(A)
Claire Evans
(C)
Julie Fly
(J)
Dianne Gallup
(D)
Cindy Green
(C)
Jesse Hickerson
(J)
Valerie Jackson
(V)
Theresa Jasion
(T)
David Jensen
(D)
Jerry Kirchner
(J)
Cheryl Mayton
(C)
Annette McDaniel
(A)
Rania Metry
(R)
Carol Pereira
(C)
Thomas Phillips
(T)
Gudaye Tasissa
(G)
Tinisha Turner
(T)
Kadie Wells
(K)
Darlene Fountain
(D)
Sarita Madell
(S)
Kimberly Crum
(K)
Kate Galligy
(K)
Kathleen Van'tHof
(K)
Laura Burgardt
(L)
Michelle Otto
(M)
Chantal Sanchez
(C)
Layla Al Sarraf
(L)
Lucey Boyle
(L)
Shalayna Woodly
(S)
Taylor Swann
(T)
Kathleen Molony
(K)
William Anguiano
(W)
Maria Martinez
(M)
Bianca Mobley
(B)
Parvin Mohazabnia
(P)
Molly Brown
(M)
Amy Taylor
(A)
Mike Gawad
(M)
Jennifer Nelson
(J)
Jennifer Marshall
(J)
Amy Monroe
(A)
Reality Price
(R)
Susan Richey
(S)
Dalia Lopez Colon
(D)
Leah Breault
(L)
Linda Lambert
(L)
Disha Goel
(D)
Pawel Kwiatkowski
(P)
Chelsea Mannie
(C)
Annie Pourney
(A)
Gabriel Hansen
(G)
Carolyn Chamberlain
(C)
Luke Murphy
(L)
Jennifer Harman
(J)
Melissa Challman
(M)
Andrew Lee
(A)
Martine Malivers
(M)
Elizabeth Menard
(E)
Bonnie Hughes
(B)
Katrin O'Grady
(K)
Mark LoGalbo
(M)
Deborah Bizjak
(D)
Fejeania Hunter
(F)
Sidney Koepp
(S)
Lukas Kost
(L)
Kimberly Teknipp
(K)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2022 Massachusetts Medical Society.
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