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The Effects of Inhaled Nitric Oxide After Fontan Operation

This study has been completed.
Sponsor:
Collaborator:
INO Therapeutics
Information provided by:
Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT00945529
First received: May 28, 2009
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide given for 54 hours after Fontan operation to improve fluid balance. The study hypothesis is that inhaled nitric oxide after Fontan operation will improve fluid balance, thus decreasing the incidence of pleural effusions and shortening hospital stay.


Condition Intervention Phase
Congenital Heart Defect
 Drug: inhaled nitric oxide
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Inhaled Nitric Oxide on Patient Morbidity and Length of Hospital Stay Following Fontan Operation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:
  • length of hospital stay following Fontan [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum post-op weight [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Daily fluid balance [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Magnitude of pleural fluid collection [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Thoracentesis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Duration of pleural effusions [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: August 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: inhaled nitric oxide
    Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
    Other Name: Inomax
  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male/female patients
  • Undergoing Fontan operation at the Nemours Cardiac Center at A. I. duPont Hospital for Children
  • Written parental permission to participate in this research study

Exclusion Criteria:

  • Any condition which the PI feels will interfere with the patient's safe and effective participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945529

Locations
United States, Delaware
A. I. duPont Hospital for Children/Nemours Cardiac Center
Wilmington, Delaware, United States, 19803
Sponsors and Collaborators
Nemours Children's Clinic
INO Therapeutics
Investigators
Principal Investigator: Ellen Spurrier, MD Nemours Children's Clinic - A. I. duPont Hospital for Children
  More Information

No publications provided

Responsible Party: Ellen Spurrier, MD, Nemours
ClinicalTrials.gov Identifier: NCT00945529     History of Changes
Other Study ID Numbers: SPURE1
Study First Received: May 28, 2009
Last Updated: May 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Nemours Children's Clinic:
Fontan

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013