Nesiritide Use Following Cardiac Surgery in Infants

NCT00281671 | Terminated Phase 1 Results DMC

• 1 other identifier: 05-12-160
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Defects, Congenital; Cardiopulmonary Bypass

Keywords

Nesiritide; Natriuretic Peptide, Brain; Heart Defects, Congenital; Cardiopulmonary Bypass; Diuretics

Outcome Measures

Primary Outcomes (1)

• Urine Output

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

  5 hours

Secondary Outcomes (3)

• Number of Participants With Hypotension and Bradycardia

  48 hours

• Urine Output

  10 hours

• Cardiac Index

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Nesiritide

EXPERIMENTAL

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

Interventions

nesiritide DRUG

nesiritide 0.015 mcg/kg/hour x 10 hours

Also known as: Natrecor

Nesiritide

Placebo DRUG

0.9% sodium chloride infusion

Also known as: 0.9% sodium chloride infusion

Placebo

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \> 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• Costello JM, Backer CL, Checchia PA, Mavroudis C, Seipelt RG, Goodman DM. Effect of cardiopulmonary bypass and surgical intervention on the natriuretic hormone system in children. J Thorac Cardiovasc Surg. 2005 Sep;130(3):822-9. doi: 10.1016/j.jtcvs.2005.03.008.

  PMID: 16153935 BACKGROUND

• Costello JM, Backer CL, Checchia PA, Mavroudis C, Seipelt RG, Goodman DM. Alterations in the natriuretic hormone system related to cardiopulmonary bypass in infants with congestive heart failure. Pediatr Cardiol. 2004 Jul-Aug;25(4):347-53. doi: 10.1007/s00246-003-0512-5.

  PMID: 14735254 BACKGROUND

• Mahle WT, Cuadrado AR, Kirshbom PM, Kanter KR, Simsic JM. Nesiritide in infants and children with congestive heart failure. Pediatr Crit Care Med. 2005 Sep;6(5):543-6. doi: 10.1097/01.pcc.0000164634.58297.9a.

  PMID: 16148814 BACKGROUND

• Simsic JM, Reddy VS, Kanter KR, Kirshbom PM, Forbess JM. Use of nesiritide (human B-type natriuretic peptide) in infants following cardiac surgery. Pediatr Cardiol. 2004 Nov-Dec;25(6):668-70. doi: 10.1007/s00246-003-0680-3.

  PMID: 14994182 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: John M. Costello, MD MPH
• Organization: Ann & Robert H. Lurie Children's Hospital of Chicago

jmcostello@luriechildrens.org

312 227 1551

Study Officials

• John M Costello, MD

  Department of Cardiology, Children's Hospital Boston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Cardiology

Study Record Dates

• First Submitted: January 23, 2006
• First Posted: January 25, 2006
• Study Start: April 8, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 27, 2020
• Results First Posted: August 27, 2020

Record last verified: 2018-05

Locations

US (1)