A Phase 1/2 interventional study of nesiritide and Placebo in Heart Defects, Congenital and Cardiopulmonary Bypass, sponsored by Boston Children's Hospital. Terminated at 1 site in United States. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2020-08-27.
Sponsored by Boston Children's Hospital · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine the effects of nesiritide on urine output and hemodynamics following cardiopulmonary bypass in infants. Safety and pharmacokinetic data will also be obtained.
Nesiritide, a recombinant human B-type natriuretic peptide, has vasodilatory, lusitropic and diuretic properties in healthy humans, and improves hemodynamics and symptoms in adults with decompensated congestive heart failure. Several retrospective case series suggest that nesiritide has beneficial effects on hemodynamics and urine output in adults and children following cardiac surgery.
The purpose of this prospective, randomized, double-blind, crossover study is to evaluate the effects of a continuous infusion of nesiritide on postoperative hemodynamics and urine output in infants with congenital heart disease who undergo cardiac surgery requiring cardiopulmonary bypass (CPB). Patients less than 1 year of age following cardiac surgery will be eligible for the study if they have received two conventional diuretics (furosemide and chlorothiazide) for at least 12 hours, yet are not effectively achieving a negative fluid balance, thus prohibiting sternal closure or tracheal extubation. Patients will be randomized to receive either a 10-hour infusion of nesiritide, a two hour washout period, followed by a 10-hour infusion of placebo, or this study drug sequence in reverse order. During the 24-hour study period, serial cardiac output measurements and BNP levels will be obtained, vital signs and intracardiac filling pressures will be recorded, and urine output will be measured.
1,007 studies on the registry are indexed under Heart Defects, Congenital; 257 are open to participants now.
This study's enrollment of 9 is below the median of 60 across 524 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In this crossover pilot study, patients are randomly assigned to receive either nesiritide or placebo infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours.
Drug: Placebo
In this crossover pilot study, patients are randomly assigned to receive either nesiritide or placebo infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours.
Drug: nesiritide
nesiritide 0.015 mcg/kg/hour x 10 hours
Also known as: Natrecor
0.9% sodium chloride infusion
Also known as: 0.9% sodium chloride infusion
Urine Output
Urine output measured in cc/kg/hour during the last 5 hours of the study drug infusion
Time frame: 5 hours
Number of Participants With Hypotension and Bradycardia
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.
Time frame: 48 hours
Urine Output
Time frame: 10 hours
Cardiac Index
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.
Time frame: Baseline (hour 0) and 6 hours after onset of study drug infusion
Recruitment: April 2006- June 2007. Location: Cardiac ICU in a large children's hospital.
| Milestone | Nesiritide First, Then Placebo | Placebo First, Then Nesiritide |
|---|---|---|
| Started | 5 | 4 |
| Completed | 5 | 4 |
| Not completed | 0 | 0 |
Urine output measured in cc/kg/hour during the last 5 hours of the study drug infusion
| cc/kg/hr | Placebo | Nesiritide |
|---|---|---|
| Urine Output | 2.9 (1.1 to 7.1) | 3.1 (0.6 to 6.4) |
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.
| Participants | Placebo | Nesiritide |
|---|---|---|
| hypotension | 0 | 0 |
| bradycardia | 0 | 0 |
| cc/kg/hr | Placebo | Nesiritide |
|---|---|---|
| Urine Output | 3.4 (1.1 to 6.0) | 4.2 (1.3 to 5.7) |
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.
| L/min/m^2 | Placebo | Nesiritide |
|---|---|---|
| baseline | 1.83 (0.95 to 3.61) | 1.90 (1.50 to 3.26) |
| 6 hours after onset of drug infusion | 1.95 (1.40 to 5.80) | 2.15 (1.42 to 3.67) |
Collected over Initiation of study interventions until 48 hours after the study drug infusions ended.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nesiritide | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Placebo | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(days) | All Study Participants |
|---|---|
| Median | 6 (4 to 103) |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 3 |
| Male | 6 |
| Race and Ethnicity Not Collected(Participants) | All Study Participants |
|---|
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 9 |
| Weight(Kg) | All Study Participants |
|---|---|
| Median | 3.5 (2.5 to 4.9) |
| Prematurity(Participants) | All Study Participants |
|---|---|
| Count of participants | 2 |
Plan to share: Undecided — Email PI for data requests.
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