Trial Outcomes & Findings for Nesiritide Use Following Cardiac Surgery in Infants (NCT NCT00281671)

Results Overview

Urine output measured in cc/kg/hour during the last 5 hours of the study drug infusion

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

5 hours

Results posted on

2020-08-27

Participant Flow

Recruitment: April 2006- June 2007. Location: Cardiac ICU in a large children's hospital.

Participant milestones

Participant milestones
Measure	Nesiritide First, Then Placebo Patients assigned to this arm received nesiritide 0.015 mcg/kg/hour for 10 hours, followed by a two hour washout period, and then a placebo infusion (0.9 normal saline) for 10 hours	Placebo First, Then Nesiritide Patients assigned to this arm received a placebo infusion (0.9 normal saline) for 10 hours, followed by a two hour washout period, and then nesiritide 0.015 mcg/kg/hour for 10 hours
Overall Study STARTED	5	4
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=9 Participants Because all participants were randomized to receive all interventions, baseline measurements are combined rather that reported by Arm/Group.
Age, Continuous	6 days n=9 Participants
Sex: Female, Male Female	3 Participants n=9 Participants
Sex: Female, Male Male	6 Participants n=9 Participants
Region of Enrollment United States	9 participants n=9 Participants
Weight	3.5 Kg n=9 Participants
Prematurity	2 Participants n=9 Participants

PRIMARY outcome

Timeframe: 5 hours

Urine output measured in cc/kg/hour during the last 5 hours of the study drug infusion

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants In this crossover pilot study, patients were randomly assigned to receive either nesiritide 0.015 mcg/kg/min or placebo IV infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours. For this arm, the data reflect the urine output during the last 5 hours of the 0.9 normal saline placebo infusion for all 9 patients.	Nesiritide n=9 Participants In this crossover pilot study, patients are randomly assigned to receive either nesiritide 0.015 mcg/kg/min or placebo IV infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours. For this arm, the data reflect the urine output during the last 5 hours of the nesiritide 0.015 mcg/kg/hour infusion for all 9 patients.
Urine Output	2.9 cc/kg/hr Interval 1.1 to 7.1	3.1 cc/kg/hr Interval 0.6 to 6.4

SECONDARY outcome

Timeframe: 48 hours

Hypotension (mean arterial blood pressure \< 40 mmHg for \> 30 minutes) that is refractory to volume administration, increased inotropic/vasopressor support, and weaning of other vasodilators (e.g., milrinone) or sedatives Bradycardia, defined as 1) a decrease in heart rate of more than 30 beats/minute from baseline following the initiation of study drug infusion that 2) results in new requirement for temporary atrial pacing or other treatment specifically to increase heart rate and 3) is not readily explainable by other conditions.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants In this crossover pilot study, patients were randomly assigned to receive either nesiritide 0.015 mcg/kg/min or placebo IV infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours. For this arm, the data reflect the urine output during the last 5 hours of the 0.9 normal saline placebo infusion for all 9 patients.	Nesiritide n=9 Participants In this crossover pilot study, patients are randomly assigned to receive either nesiritide 0.015 mcg/kg/min or placebo IV infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours. For this arm, the data reflect the urine output during the last 5 hours of the nesiritide 0.015 mcg/kg/hour infusion for all 9 patients.
Number of Participants With Hypotension and Bradycardia bradycardia	0 Participants	0 Participants
Number of Participants With Hypotension and Bradycardia hypotension	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 hours

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants In this crossover pilot study, patients were randomly assigned to receive either nesiritide 0.015 mcg/kg/min or placebo IV infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours. For this arm, the data reflect the urine output during the last 5 hours of the 0.9 normal saline placebo infusion for all 9 patients.	Nesiritide n=9 Participants In this crossover pilot study, patients are randomly assigned to receive either nesiritide 0.015 mcg/kg/min or placebo IV infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours. For this arm, the data reflect the urine output during the last 5 hours of the nesiritide 0.015 mcg/kg/hour infusion for all 9 patients.
Urine Output	3.4 cc/kg/hr Interval 1.1 to 6.0	4.2 cc/kg/hr Interval 1.3 to 5.7

SECONDARY outcome

Timeframe: Baseline (hour 0) and 6 hours after onset of study drug infusion

Population: Cardiac index was only able to be measured for 4 of the 9 subjects enrolled in the trial.

Cardiac index is based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m\^2) to yield the cardiac index. Cardiac index was calculated in patients with an SVC catheter (previously placed for clinical indications) using the Fick principle using measured oxygen consumption (VO2), hemoglobin levels, and the difference between arterial and superior vena cava oxygen saturation. Oxygen consumption was measured using a real-time gas exchange technique with the Deltatrack II gas sensor.

Outcome measures

Outcome measures
Measure	Placebo n=4 Participants In this crossover pilot study, patients were randomly assigned to receive either nesiritide 0.015 mcg/kg/min or placebo IV infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours. For this arm, the data reflect the urine output during the last 5 hours of the 0.9 normal saline placebo infusion for all 9 patients.	Nesiritide n=4 Participants In this crossover pilot study, patients are randomly assigned to receive either nesiritide 0.015 mcg/kg/min or placebo IV infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours. For this arm, the data reflect the urine output during the last 5 hours of the nesiritide 0.015 mcg/kg/hour infusion for all 9 patients.
Cardiac Index baseline	1.83 L/min/m^2 Interval 0.95 to 3.61	1.90 L/min/m^2 Interval 1.5 to 3.26
Cardiac Index 6 hours after onset of drug infusion	1.95 L/min/m^2 Interval 1.4 to 5.8	2.15 L/min/m^2 Interval 1.42 to 3.67

Adverse Events

Nesiritide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John M. Costello, MD MPH

Ann & Robert H. Lurie Children's Hospital of Chicago

Phone: 312 227 1551

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place