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Nesiritide Use Following Cardiac Surgery in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00281671
Recruitment Status : Terminated (Slow patient enrollment.)
First Posted : January 25, 2006
Results First Posted : August 27, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
John M Costello, Boston Children's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Defects, Congenital Cardiopulmonary Bypass Drug: nesiritide Drug: Placebo Phase 1 Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of the Effects of Nesiritide on Hemodynamics and Urine Output Following Cardiopulmonary Bypass in Infants
Study Start Date : April 8, 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Nesiritide

Arm Intervention/treatment
Placebo Comparator: 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: Placebo
0.9% sodium chloride infusion
Other Name: 0.9% sodium chloride infusion

Experimental: Nesiritide
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
Other Name: Natrecor




Primary Outcome Measures :
  1. Urine Output [ Time Frame: 5 hours ]
    Urine output measured in cc/kg/hour during the last 5 hours of the study drug infusion


Secondary Outcome Measures :
  1. Number of Participants With Hypotension and Bradycardia [ Time Frame: 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.


  2. Urine Output [ Time Frame: 10 hours ]
  3. Cardiac Index [ Time Frame: Baseline (hour 0) and 6 hours after onset of study drug infusion ]
    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.



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 48 hours after cardiac surgery requiring cardiopulmonary bypass
  • < 1 year of age
  • Receiving chlorothiazide and furosemide for > 12 hours
  • Urine output < 4 cc/kg/hour, or fluid intake > output for 2 consecutive days
  • Receiving mechanical ventilation
  • Presence of body wall edema on CXR, defined as a radiologic index of > 2
  • Plan for > 24 hrs further diuresis before chest closure or extubation

Exclusion Criteria:

  • Age > 365 days at the time of enrollment
  • Corrected estimated gestational age < 35 weeks at the time of enrollment
  • Serum creatinine > 2.0 mg/dL at the time of enrollment
  • Significant hemodynamic instability at the time of enrollment
  • Lack of dedicated intravenous access for nesiritide infusion
  • Lack of arterial line for continuous blood pressure monitoring
  • Lack of a Foley catheter for continuous urine collection
  • Enrollment in another research study such that the outcomes of either study may be confounded by participation in this study, or such that the amount of blood drawn for research purposes becomes excessive.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00281671


Locations
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United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: John M Costello, MD Department of Cardiology, Children's Hospital Boston
Publications:
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Responsible Party: John M Costello, Attending Physician, Department of Cardiology, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00281671    
Other Study ID Numbers: 05-12-160
First Posted: January 25, 2006    Key Record Dates
Results First Posted: August 27, 2020
Last Update Posted: August 27, 2020
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Email PI for data requests.
Keywords provided by John M Costello, Boston Children's Hospital:
Nesiritide
Natriuretic Peptide, Brain
Heart Defects, Congenital
Cardiopulmonary Bypass
Diuretics
Additional relevant MeSH terms:
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Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs