Trial Outcomes & Findings for Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease (NCT NCT00590018)

NCT ID: NCT00590018

Last Updated: 2016-05-26

Results Overview

Change in mean blood pressure recorded prior to (15 minutes prior to study drug) and subsequent to medication/placebo administration (at 2 days post drug administration).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: 2 days
• Results posted on: 2016-05-26

Participant Flow

Participant milestones

Measure	Hydrocortisone Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --\> 25mg/m2/day) over 5 days intravenously.	Placebo Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
Overall Study STARTED	9	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease

Baseline characteristics by cohort

Measure	Hydrocortisone n=9 Participants Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --\> 25mg/m2/day) over 5 days intravenously.	Placebo n=9 Participants Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 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	10 days STANDARD_DEVIATION 10.58 • n=5 Participants	7 days STANDARD_DEVIATION 4.12 • n=7 Participants	8.5 days STANDARD_DEVIATION 7.94 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants
Inotrope score	23.46 units on a scale STANDARD_DEVIATION 3.79 • n=5 Participants	22.11 units on a scale STANDARD_DEVIATION 2.31 • n=7 Participants	22.78 units on a scale STANDARD_DEVIATION 3.12 • n=5 Participants

PRIMARY outcome

Timeframe: 2 days

Change in mean blood pressure recorded prior to (15 minutes prior to study drug) and subsequent to medication/placebo administration (at 2 days post drug administration).

Outcome measures

Measure	Hydrocortisone n=9 Participants Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --\> 25mg/m2/day) over 5 days intravenously.	Placebo n=9 Participants Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
Blood Pressure.	6 mmHg Standard Deviation 7.86	5.89 mmHg Standard Deviation 9.24

SECONDARY outcome

Timeframe: 2 days

Inotrope score: epinephrine (mcg/kg/min x 100) + norepinephrine (mcg/kg/min x 100) + phenylephrine (mcg/kg/min x 100) + dopamine (mcg/kg/min x1) + dobutamine (mcg/kg/min x 1) + milrinone (mcg/kg/min x15). A lower inotrope score is better with the minimum being 0 and the maximum being 85.

Outcome measures

Measure	Hydrocortisone n=9 Participants Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --\> 25mg/m2/day) over 5 days intravenously.	Placebo n=9 Participants Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
Change in Inotrope Score. This is the Change in the Inotrope Score Between 15 Minutes Prior to Drug Administration and at 2 Days After Drug Administration.	8.83 units on a scale Standard Deviation 9.61	7.17 units on a scale Standard Deviation 4.8

Adverse Events

Hydrocortisone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Hydrocortisone n=9 participants at risk Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --\> 25mg/m2/day) over 5 days intravenously.	Placebo n=9 participants at risk Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
Cardiac disorders Death	0.00% 0/9 • Duration of the the admission time in the intensive care unit and hospital stay (duration of the study). This time period averaged 45 days.	11.1% 1/9 • Number of events 1 • Duration of the the admission time in the intensive care unit and hospital stay (duration of the study). This time period averaged 45 days.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heather Dickerson

Baylor College of Medicine

Phone: 832-826-5637

Email: had@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place