Trial · NCT03229538
STeroids to REduce Systemic Inflammation After Infant Heart Surgery
NCT03229538, Phase 3, Completed, Kevin Hill; results first posted 2023-05-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. STeroids to REduce Systemic Inflammation After Infant Heart Surgery. Trials, record NCT03229538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03229538
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- STeroids to REduce Systemic Inflammation After Infant Heart Surgery
- NCT number
- NCT03229538
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,263 participants, actual
- Lead sponsor
- Kevin Hill
- Conditions
- Congenital Heart Disease in Children, Inflammatory Response
- Interventions
- Methylprednisolone, Isotonic saline
- First posted
- 2017-07-25
- Last updated
- 2026-01-05
- Results first posted
- 2023-05-10
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome | Until hospital discharge, up to 4 months | 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. |
| Secondary | 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 | up to 30 days | |
| Secondary | Number of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking Categories | Until hospital discharge, up to 4 months | The 7 highest global ranking categories range from 91 (postoperative length of hospital stay \> 90 days) to 97 (operative mortality). |
| Secondary | Number of Participants With a Post-operative Length of Stay Greater Than 90 Days | Until hospital discharge, up to 4 months | Calculated as discharge date minus surgery date. |
| Secondary | Number of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days) | Until hospital discharge, up to 4 months | |
| Secondary | Number of Participants With Post-operative Low Cardiac Output Syndrome | Until hospital discharge, up to 4 months | Based upon the STS-CHSD registry defined "cardiac dysfunction resulting in low cardiac output" complication variable. |
| Secondary | 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. | Until hospital discharge, up to 4 months | |
| Secondary | Number of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge. | Until hospital discharge, up to 4 months | |
| Secondary | PK/PD - Time to Maximum Concentration (Tmax) | 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) | |
| Secondary | PK/PD - Maximum Concentration (Cmax) | 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) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome | Until hospital discharge, up to 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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 | up to 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking Categories | Until hospital discharge, up to 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Post-operative Length of Stay Greater Than 90 Days | Until hospital discharge, up to 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days) | Until hospital discharge, up to 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Post-operative Low Cardiac Output Syndrome | Until hospital discharge, up to 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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. | Until hospital discharge, up to 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge. | Until hospital discharge, up to 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | PK/PD - Time to Maximum Concentration (Tmax) | 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) | Data not collected. | ||
| SECONDARY | PK/PD - Maximum Concentration (Cmax) | 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) | Data not collected. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome | Methylprednisolone Arm | Rank = 97 | 12 | Participants | |
| Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome | Placebo Arm | Rank = 97 | 17 | Participants | |
| Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome | Methylprednisolone Arm | Rank = 96 | 3 | Participants | |
| Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome | Placebo Arm | Rank = 96 | 7 | Participants | |
| Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome | Methylprednisolone Arm | Rank = 95 | 4 | Participants | |
| Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome | Placebo Arm | Rank = 95 | 8 | Participants | |
| Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome | Methylprednisolone Arm | Rank = 94 | 44 | Participants | |
| Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome | Placebo Arm | Rank = 94 | 36 | Participants | |
| Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome | Methylprednisolone Arm | Rank = 93 | 12 | Participants | |
| Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome | Placebo Arm | Rank = 93 | 30 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methylprednisolone Arm | 599 | |
| Overall Study | STARTED | Placebo Arm | 601 | |
| Overall Study | COMPLETED | Methylprednisolone Arm | 599 | |
| Overall Study | COMPLETED | Placebo Arm | 601 | |
| Overall Study | NOT COMPLETED | Methylprednisolone Arm | 0 | |
| Overall Study | NOT COMPLETED | Placebo Arm | 0 |
Source ClinicalTrials.gov
Adverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arrhythmia | Cardiac disorders | Methylprednisolone Arm | 155 | 599 | |
| other | Arrhythmia | Cardiac disorders | Placebo Arm | 176 | 601 | |
| other | Cardiac dysfunction | Cardiac disorders | Methylprednisolone Arm | 133 | 599 | |
| other | Cardiac dysfunction | Cardiac disorders | Placebo Arm | 135 | 601 | |
| other | Cardiac Arrest | Cardiac disorders | Methylprednisolone Arm | 31 | 599 | |
| other | Cardiac Arrest | Cardiac disorders | Placebo Arm | 37 | 601 | |
| other | Pericardial effusion | Cardiac disorders | Methylprednisolone Arm | 14 | 599 | |
| other | Pericardial effusion | Cardiac disorders | Placebo Arm | 21 | 601 | |
| other | Intracardiac thrombus | Cardiac disorders | Methylprednisolone Arm | 2 | 599 | |
| other | Intracardiac thrombus | Cardiac disorders | Placebo Arm | 1 | 601 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methylprednisolone Arm | 12 | 599 |
| Total, all-cause mortality | Placebo Arm | 17 | 601 |
| Total, other adverse events | Methylprednisolone Arm | 155 | 599 |
| Total, other adverse events | Placebo Arm | 176 | 601 |
| Total, serious adverse events | Methylprednisolone Arm | 2 | 599 |
| Total, serious adverse events | Placebo Arm | 0 | 601 |
Source ClinicalTrials.gov
Papers25
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01TR001803 | Leveraging existing registry resources to facilitate clinical trials | LI, JENNIFER S; BALDWIN, H SCOTT; JACOBS, JEFFREY PHILLIP; JACOBS, MARSHALL LEWIS | DUKE UNIVERSITY | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2016 to 2020 |
Source NIH RePORTER
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Methylprednisolone Arm vs Placebo Arm: Number of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days) | Trial comparisons |
| Methylprednisolone Arm vs Placebo Arm: Number of Participants With Post-operative Low Cardiac Output Syndrome | Trial comparisons |
| Methylprednisolone Arm vs Placebo Arm: 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 | Trial comparisons |
| Methylprednisolone Arm vs Placebo Arm: Number of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking Categories | Trial comparisons |
| Methylprednisolone Arm vs Placebo Arm: Number of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge. | Trial comparisons |
| Methylprednisolone Arm vs Placebo Arm: Number of Participants With a Post-operative Length of Stay Greater Than 90 Days | Trial comparisons |
Methylprednisolone Arm vs Placebo Arm: 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. | Trial comparisons |
| Methylprednisolone Arm vs Placebo Arm: deaths from any cause | Trial comparisons |
| Methylprednisolone Arm vs Placebo Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03229538
GET https://conductscience.org/api/trials/v1/NCT03229538/results?page=2