Trial Outcomes & Findings for Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass (NCT NCT00934843)

Results Overview

The presence of low cardiac output syndrome (LCOS) was defined by the same definition used in the PRIMACORP study (Hoffman TM.et.al. Circulation 2003 107:996-1002). Specifically, if there were clinical signs and symptoms of low cardiac output (e.g., tachycardia, oliguria, cold extremities, cardiac arrest, etc.) which required one or more of the following interventions: mechanical circulatory support, the escalation of existing pharmacological circulatory support to \>100% over baseline, or the initiation of new pharmacological circulatory support.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

77 participants

Primary outcome timeframe

36 hours

Results posted on

2011-12-09

Participant Flow

All inpatient neonates (≤ 30 days of age), scheduled to undergo cardiac surgery involving cardiopulmonary bypass from the time period of July 2007 through July 2009 were eligible for this study.

Participant milestones

Participant milestones
Measure	MP Single Dose Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.	MP Two Dose Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
Overall Study STARTED	37	40
Overall Study COMPLETED	37	39
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	MP Single Dose Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.	MP Two Dose Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
Overall Study Protocol Violation	0	1

Baseline Characteristics

Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MP Single Dose n=37 Participants Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.	MP Two Dose n=40 Participants Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.	Total n=77 Participants Total of all reporting groups
Age, Categorical <=18 years	37 Participants n=5 Participants	40 Participants n=7 Participants	77 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	8.2 days STANDARD_DEVIATION 5.0 • n=5 Participants	9.4 days STANDARD_DEVIATION 6.3 • n=7 Participants	8.8 days STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	40 participants n=7 Participants	77 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 hours

The presence of low cardiac output syndrome (LCOS) was defined by the same definition used in the PRIMACORP study (Hoffman TM.et.al. Circulation 2003 107:996-1002). Specifically, if there were clinical signs and symptoms of low cardiac output (e.g., tachycardia, oliguria, cold extremities, cardiac arrest, etc.) which required one or more of the following interventions: mechanical circulatory support, the escalation of existing pharmacological circulatory support to \>100% over baseline, or the initiation of new pharmacological circulatory support.

Outcome measures

Outcome measures
Measure	MP Single Dose n=37 Participants Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)	MP Two Dose n=39 Participants Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.	17 participants	15 participants

SECONDARY outcome

Timeframe: over the first 36 hours after surgery

The inotropic score was calculated by the equation using drug dosages in micrograms/kg/min, (dopamine+dobutamine) + (milrinonex10) + (epinephrinex100) and recorded hourly upon arrival to the ICUthrough 36 hours postoperatively. The highest score during this timeframe was recorded. This score converts dosages of commonly used inotropic medications into a score. The higher the score the more inotropic medications required. The minimum score would be zero indicating no inotropic medications were used. There is no maximum score.

Outcome measures

Outcome measures
Measure	MP Single Dose n=37 Participants Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)	MP Two Dose n=39 Participants Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
Inotropic Score	14.4 Scores on a scale Standard Deviation 3.6	15.0 Scores on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: at 36 hours and 30 days

Number of participants who died of any cause between 36 hours and 30 days following cardiac surgery

Outcome measures

Outcome measures
Measure	MP Single Dose n=37 Participants Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)	MP Two Dose n=39 Participants Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery	1 participants	0 participants

SECONDARY outcome

Timeframe: over 36 hours

Total urine output in mL over the first 36 hours after cardiac surgery

Outcome measures

Outcome measures
Measure	MP Single Dose n=37 Participants Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)	MP Two Dose n=39 Participants Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
Urine Output	498 mL Standard Deviation 227	453 mL Standard Deviation 213

SECONDARY outcome

Timeframe: over 36 hours

Total amount of all fluids in and out during the first 36 hours postoperatively in mL.

Outcome measures

Outcome measures
Measure	MP Single Dose n=37 Participants Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)	MP Two Dose n=39 Participants Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
Total Intake/Output of Fluid Total Fluid in at 36 hr	575 mL Standard Deviation 145	586 mL Standard Deviation 156
Total Intake/Output of Fluid Total Fluid out at 36 hr	600 mL Standard Deviation 250	558 mL Standard Deviation 203

Adverse Events

MP Single Dose

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

MP Two Dose

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MP Single Dose n=37 participants at risk Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.	MP Two Dose n=39 participants at risk Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
Cardiac disorders Death	2.7% 1/37 • Number of events 1	0.00% 0/39

Other adverse events

Other adverse events
Measure	MP Single Dose n=37 participants at risk Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.	MP Two Dose n=39 participants at risk Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
Infections and infestations Infection	13.5% 5/37 • Number of events 5	12.8% 5/39 • Number of events 5
Cardiac disorders Poor wound healing	2.7% 1/37 • Number of events 1	12.8% 5/39 • Number of events 5

Additional Information

Dr. Eric Graham

Medical University of South Carolina

Phone: 843-792-8704

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place