Trial Outcomes & Findings for STeroids to REduce Systemic Inflammation After Infant Heart Surgery (NCT NCT03229538)
NCT ID: NCT03229538
Last Updated: 2026-01-05
Results Overview
A composite mortality, major morbidity and length of stay global rank endpoint with endpoints ranked according to severity. For this endpoint, each randomized patient will be assigned a rank based upon their most-severe outcome. Rank of 91 = Post-operative length of stay \> 90 days, 92 = Post-op cardiac arrest, multi-system organ failure, renal failure with temporary dialysis, or prolonged ventilator support, 93 = Reoperation for bleeding, unplanned delayed sternal closure, or post-op unplanned interventional cardiac catheterization, 94 = Post-operative mechanical circulatory support or unplanned cardiac reoperation (exclusive of reoperation for bleeding), 95 = Renal failure with permanent dialysis, neurologic deficit persistent at discharge, or respiratory failure requiring tracheostomy; 96 = Heart transplant (during hospitalization); 97 = Operative mortality. Ranks 1 through 90 correspond to the post-operative length of stay in days.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1263 participants
Primary outcome timeframe
Until hospital discharge, up to 4 months
Results posted on
2026-01-05
Participant Flow
1263 patients consented and randomized; 63 did not receive study drug and are excluded from final analysis.
Participant milestones
| Measure |
Methylprednisolone Arm
IV Methylprednisolone
Methylprednisolone: IV Steroid pre-operative and intra-operative
Study drug will be administered 8 to 12 hours before the anticipated start time of surgery and in the operating room at the time of initiation of cardiopulmonary bypass.
|
Placebo Arm
IV Isotonic Saline
Isotonic saline: Isotonic saline pre-operative and intra-operative
Placebo will be administered 8 to 12 hours before the anticipated start time of surgery and in the operating room at the time of initiation of cardiopulmonary bypass.
|
|---|---|---|
|
Overall Study
STARTED
|
599
|
601
|
|
Overall Study
COMPLETED
|
599
|
601
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data not collected on 32 participants.
Baseline characteristics by cohort
| Measure |
Methylprednisolone Arm
n=599 Participants
IV Methylprednisolone
Methylprednisolone: IV Steroid pre-operative and intra-operative
|
Placebo Arm
n=601 Participants
IV Isotonic Saline
Isotonic saline: Isotonic saline pre-operative and intra-operative
|
Total
n=1200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
126 days
n=599 Participants
|
124 days
n=601 Participants
|
125 days
n=1200 Participants
|
|
Sex: Female, Male
Female
|
279 Participants
n=599 Participants
|
267 Participants
n=601 Participants
|
546 Participants
n=1200 Participants
|
|
Sex: Female, Male
Male
|
320 Participants
n=599 Participants
|
334 Participants
n=601 Participants
|
654 Participants
n=1200 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
80 Participants
n=599 Participants
|
63 Participants
n=601 Participants
|
143 Participants
n=1200 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
519 Participants
n=599 Participants
|
538 Participants
n=601 Participants
|
1057 Participants
n=1200 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=599 Participants
|
0 Participants
n=601 Participants
|
0 Participants
n=1200 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=585 Participants • Data not collected on 32 participants.
|
4 Participants
n=583 Participants • Data not collected on 32 participants.
|
9 Participants
n=1168 Participants • Data not collected on 32 participants.
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=585 Participants • Data not collected on 32 participants.
|
12 Participants
n=583 Participants • Data not collected on 32 participants.
|
27 Participants
n=1168 Participants • Data not collected on 32 participants.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=585 Participants • Data not collected on 32 participants.
|
0 Participants
n=583 Participants • Data not collected on 32 participants.
|
4 Participants
n=1168 Participants • Data not collected on 32 participants.
|
|
Race (NIH/OMB)
Black or African American
|
90 Participants
n=585 Participants • Data not collected on 32 participants.
|
102 Participants
n=583 Participants • Data not collected on 32 participants.
|
192 Participants
n=1168 Participants • Data not collected on 32 participants.
|
|
Race (NIH/OMB)
White
|
428 Participants
n=585 Participants • Data not collected on 32 participants.
|
425 Participants
n=583 Participants • Data not collected on 32 participants.
|
853 Participants
n=1168 Participants • Data not collected on 32 participants.
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=585 Participants • Data not collected on 32 participants.
|
15 Participants
n=583 Participants • Data not collected on 32 participants.
|
28 Participants
n=1168 Participants • Data not collected on 32 participants.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=585 Participants • Data not collected on 32 participants.
|
25 Participants
n=583 Participants • Data not collected on 32 participants.
|
55 Participants
n=1168 Participants • Data not collected on 32 participants.
|
|
Region of Enrollment
United States
|
599 Participants
n=599 Participants
|
601 Participants
n=601 Participants
|
1200 Participants
n=1200 Participants
|
PRIMARY outcome
Timeframe: Until hospital discharge, up to 4 monthsA composite mortality, major morbidity and length of stay global rank endpoint with endpoints ranked according to severity. For this endpoint, each randomized patient will be assigned a rank based upon their most-severe outcome. Rank of 91 = Post-operative length of stay \> 90 days, 92 = Post-op cardiac arrest, multi-system organ failure, renal failure with temporary dialysis, or prolonged ventilator support, 93 = Reoperation for bleeding, unplanned delayed sternal closure, or post-op unplanned interventional cardiac catheterization, 94 = Post-operative mechanical circulatory support or unplanned cardiac reoperation (exclusive of reoperation for bleeding), 95 = Renal failure with permanent dialysis, neurologic deficit persistent at discharge, or respiratory failure requiring tracheostomy; 96 = Heart transplant (during hospitalization); 97 = Operative mortality. Ranks 1 through 90 correspond to the post-operative length of stay in days.
Outcome measures
| Measure |
Methylprednisolone Arm
n=599 Participants
IV Methylprednisolone
Methylprednisolone: IV Steroid pre-operative and intra-operative
|
Placebo Arm
n=601 Participants
IV Isotonic Saline
Isotonic saline: Isotonic saline pre-operative and intra-operative
|
|---|---|---|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 97
|
12 Participants
|
17 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 96
|
3 Participants
|
7 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 95
|
4 Participants
|
8 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 94
|
44 Participants
|
36 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 93
|
12 Participants
|
30 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 92
|
24 Participants
|
22 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 91
|
4 Participants
|
2 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 81-90
|
0 Participants
|
1 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 71-80
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 61-70
|
2 Participants
|
5 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 51-60
|
5 Participants
|
3 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 41-50
|
6 Participants
|
7 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 31-40
|
14 Participants
|
18 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 21-30
|
44 Participants
|
46 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 11-20
|
115 Participants
|
112 Participants
|
|
Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome
Rank = 0-10
|
310 Participants
|
287 Participants
|
SECONDARY outcome
Timeframe: up to 30 daysOutcome measures
| Measure |
Methylprednisolone Arm
n=599 Participants
IV Methylprednisolone
Methylprednisolone: IV Steroid pre-operative and intra-operative
|
Placebo Arm
n=601 Participants
IV Isotonic Saline
Isotonic saline: Isotonic saline pre-operative and intra-operative
|
|---|---|---|
|
Number of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drug
|
12 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Until hospital discharge, up to 4 monthsThe 7 highest global ranking categories range from 91 (postoperative length of hospital stay \> 90 days) to 97 (operative mortality).
Outcome measures
| Measure |
Methylprednisolone Arm
n=599 Participants
IV Methylprednisolone
Methylprednisolone: IV Steroid pre-operative and intra-operative
|
Placebo Arm
n=601 Participants
IV Isotonic Saline
Isotonic saline: Isotonic saline pre-operative and intra-operative
|
|---|---|---|
|
Number of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking Categories
|
103 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: Until hospital discharge, up to 4 monthsCalculated as discharge date minus surgery date.
Outcome measures
| Measure |
Methylprednisolone Arm
n=599 Participants
IV Methylprednisolone
Methylprednisolone: IV Steroid pre-operative and intra-operative
|
Placebo Arm
n=601 Participants
IV Isotonic Saline
Isotonic saline: Isotonic saline pre-operative and intra-operative
|
|---|---|---|
|
Number of Participants With a Post-operative Length of Stay Greater Than 90 Days
|
18 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Until hospital discharge, up to 4 monthsOutcome measures
| Measure |
Methylprednisolone Arm
n=599 Participants
IV Methylprednisolone
Methylprednisolone: IV Steroid pre-operative and intra-operative
|
Placebo Arm
n=601 Participants
IV Isotonic Saline
Isotonic saline: Isotonic saline pre-operative and intra-operative
|
|---|---|---|
|
Number of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days)
|
41 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Until hospital discharge, up to 4 monthsBased upon the STS-CHSD registry defined "cardiac dysfunction resulting in low cardiac output" complication variable.
Outcome measures
| Measure |
Methylprednisolone Arm
n=599 Participants
IV Methylprednisolone
Methylprednisolone: IV Steroid pre-operative and intra-operative
|
Placebo Arm
n=601 Participants
IV Isotonic Saline
Isotonic saline: Isotonic saline pre-operative and intra-operative
|
|---|---|---|
|
Number of Participants With Post-operative Low Cardiac Output Syndrome
|
31 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Until hospital discharge, up to 4 monthsOutcome measures
| Measure |
Methylprednisolone Arm
n=599 Participants
IV Methylprednisolone
Methylprednisolone: IV Steroid pre-operative and intra-operative
|
Placebo Arm
n=601 Participants
IV Isotonic Saline
Isotonic saline: Isotonic saline pre-operative and intra-operative
|
|---|---|---|
|
Number of Participants With Occurrence of Any One or More of the Following STS-CHSD-defined Major Post-operative Infectious Complications: Postprocedural Infective Endocarditis, Pneumonia, Sepsis, Deep Wound Infection, Mediastinitis.
|
31 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Until hospital discharge, up to 4 monthsOutcome measures
| Measure |
Methylprednisolone Arm
n=599 Participants
IV Methylprednisolone
Methylprednisolone: IV Steroid pre-operative and intra-operative
|
Placebo Arm
n=601 Participants
IV Isotonic Saline
Isotonic saline: Isotonic saline pre-operative and intra-operative
|
|---|---|---|
|
Number of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge.
|
237 Participants
|
264 Participants
|
SECONDARY outcome
Timeframe: Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB)Population: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB)Population: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB)Population: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB)Population: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-2nd dose; a minimum of 2 of any of the following 5 time points (0-30 min after the start of CPB, 0-30 min after MUF, 1-2 hrs after CPB end, 4-6 hrs after CPB end, or 16-24 hrs after CPB end); and 36-48 hrs after CPB endPopulation: Data not collected.
Only to be collected at select centers and in those patients whose parent/legally authorized representative have granted consent to blood draws
Outcome measures
Outcome data not reported
Adverse Events
Methylprednisolone Arm
Serious events: 2 serious events
Other events: 155 other events
Deaths: 12 deaths
Placebo Arm
Serious events: 0 serious events
Other events: 176 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Methylprednisolone Arm
n=599 participants at risk
IV Methylprednisolone
Methylprednisolone: IV Steroid pre-operative and intra-operative
|
Placebo Arm
n=601 participants at risk
IV Isotonic Saline
Isotonic saline: Isotonic saline pre-operative and intra-operative
|
|---|---|---|
|
Cardiac disorders
Cardiac dysfunction
|
0.17%
1/599 • Until hospital discharge, up to 4 months
|
0.00%
0/601 • Until hospital discharge, up to 4 months
|
|
Vascular disorders
Hypotension
|
0.17%
1/599 • Until hospital discharge, up to 4 months
|
0.00%
0/601 • Until hospital discharge, up to 4 months
|
|
Infections and infestations
Enterovirus infection
|
0.17%
1/599 • Until hospital discharge, up to 4 months
|
0.00%
0/601 • Until hospital discharge, up to 4 months
|
|
Infections and infestations
Rhinovirus infection
|
0.17%
1/599 • Until hospital discharge, up to 4 months
|
0.00%
0/601 • Until hospital discharge, up to 4 months
|
Other adverse events
| Measure |
Methylprednisolone Arm
n=599 participants at risk
IV Methylprednisolone
Methylprednisolone: IV Steroid pre-operative and intra-operative
|
Placebo Arm
n=601 participants at risk
IV Isotonic Saline
Isotonic saline: Isotonic saline pre-operative and intra-operative
|
|---|---|---|
|
Vascular disorders
Haemorrhage
|
1.2%
7/599 • Until hospital discharge, up to 4 months
|
3.5%
21/601 • Until hospital discharge, up to 4 months
|
|
Vascular disorders
Deep vein thrombsis
|
1.2%
7/599 • Until hospital discharge, up to 4 months
|
2.3%
14/601 • Until hospital discharge, up to 4 months
|
|
Investigations
Catheterization cardiac
|
3.7%
22/599 • Until hospital discharge, up to 4 months
|
5.5%
33/601 • Until hospital discharge, up to 4 months
|
|
Nervous system disorders
Seizure
|
1.8%
11/599 • Until hospital discharge, up to 4 months
|
2.2%
13/601 • Until hospital discharge, up to 4 months
|
|
Nervous system disorders
Cerebrovascular accident
|
1.7%
10/599 • Until hospital discharge, up to 4 months
|
1.00%
6/601 • Until hospital discharge, up to 4 months
|
|
Nervous system disorders
Nervous system disorder
|
0.33%
2/599 • Until hospital discharge, up to 4 months
|
0.50%
3/601 • Until hospital discharge, up to 4 months
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.17%
1/599 • Until hospital discharge, up to 4 months
|
0.33%
2/601 • Until hospital discharge, up to 4 months
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.50%
3/599 • Until hospital discharge, up to 4 months
|
1.00%
6/601 • Until hospital discharge, up to 4 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.67%
4/599 • Until hospital discharge, up to 4 months
|
0.67%
4/601 • Until hospital discharge, up to 4 months
|
|
Cardiac disorders
Cardiac Arrest
|
5.2%
31/599 • Until hospital discharge, up to 4 months
|
6.2%
37/601 • Until hospital discharge, up to 4 months
|
|
Cardiac disorders
Pericardial effusion
|
2.3%
14/599 • Until hospital discharge, up to 4 months
|
3.5%
21/601 • Until hospital discharge, up to 4 months
|
|
Cardiac disorders
Intracardiac thrombus
|
0.33%
2/599 • Until hospital discharge, up to 4 months
|
0.17%
1/601 • Until hospital discharge, up to 4 months
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
20.9%
125/599 • Until hospital discharge, up to 4 months
|
22.5%
135/601 • Until hospital discharge, up to 4 months
|
|
Injury, poisoning and procedural complications
Procedural complication
|
6.8%
41/599 • Until hospital discharge, up to 4 months
|
7.0%
42/601 • Until hospital discharge, up to 4 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.8%
11/599 • Until hospital discharge, up to 4 months
|
1.5%
9/601 • Until hospital discharge, up to 4 months
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.67%
4/599 • Until hospital discharge, up to 4 months
|
0.50%
3/601 • Until hospital discharge, up to 4 months
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
0.17%
1/599 • Until hospital discharge, up to 4 months
|
0.17%
1/601 • Until hospital discharge, up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.4%
74/599 • Until hospital discharge, up to 4 months
|
13.8%
83/601 • Until hospital discharge, up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
6.0%
36/599 • Until hospital discharge, up to 4 months
|
6.2%
37/601 • Until hospital discharge, up to 4 months
|
|
Skin and subcutaneous tissue disorders
Vocal cord dysfunction
|
4.5%
27/599 • Until hospital discharge, up to 4 months
|
5.8%
35/601 • Until hospital discharge, up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
14/599 • Until hospital discharge, up to 4 months
|
4.5%
27/601 • Until hospital discharge, up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.5%
15/599 • Until hospital discharge, up to 4 months
|
3.2%
19/601 • Until hospital discharge, up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
1.7%
10/599 • Until hospital discharge, up to 4 months
|
1.5%
9/601 • Until hospital discharge, up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
7/599 • Until hospital discharge, up to 4 months
|
1.2%
7/601 • Until hospital discharge, up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertensive crisis
|
0.50%
3/599 • Until hospital discharge, up to 4 months
|
0.50%
3/601 • Until hospital discharge, up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/599 • Until hospital discharge, up to 4 months
|
0.17%
1/601 • Until hospital discharge, up to 4 months
|
|
Surgical and medical procedures
Cardiac operation
|
5.0%
30/599 • Until hospital discharge, up to 4 months
|
5.8%
35/601 • Until hospital discharge, up to 4 months
|
|
Surgical and medical procedures
Ventricular assist device insertion
|
5.2%
31/599 • Until hospital discharge, up to 4 months
|
4.2%
25/601 • Until hospital discharge, up to 4 months
|
|
Surgical and medical procedures
Hospitalization
|
3.2%
19/599 • Until hospital discharge, up to 4 months
|
4.5%
27/601 • Until hospital discharge, up to 4 months
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
1.2%
7/599 • Until hospital discharge, up to 4 months
|
1.3%
8/601 • Until hospital discharge, up to 4 months
|
|
Infections and infestations
Wound infection
|
2.3%
14/599 • Until hospital discharge, up to 4 months
|
3.5%
21/601 • Until hospital discharge, up to 4 months
|
|
Infections and infestations
Sepsis
|
3.7%
22/599 • Until hospital discharge, up to 4 months
|
1.8%
11/601 • Until hospital discharge, up to 4 months
|
|
Infections and infestations
Pneumonia
|
1.2%
7/599 • Until hospital discharge, up to 4 months
|
1.8%
11/601 • Until hospital discharge, up to 4 months
|
|
Infections and infestations
Mediastinitis
|
0.67%
4/599 • Until hospital discharge, up to 4 months
|
0.50%
3/601 • Until hospital discharge, up to 4 months
|
|
Vascular disorders
Venous occlusion
|
2.0%
12/599 • Until hospital discharge, up to 4 months
|
3.2%
19/601 • Until hospital discharge, up to 4 months
|
|
Cardiac disorders
Arrhythmia
|
25.9%
155/599 • Until hospital discharge, up to 4 months
|
29.3%
176/601 • Until hospital discharge, up to 4 months
|
|
Cardiac disorders
Cardiac dysfunction
|
22.2%
133/599 • Until hospital discharge, up to 4 months
|
22.5%
135/601 • Until hospital discharge, up to 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place