Nitric Oxide Administration for Acute Respiratory Distress Syndrome

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00240487
First received: October 14, 2005
Last updated: February 10, 2009
Last verified: February 2009
  Purpose

This research project is an open-label, randomized crossover study for the use of Nitric Oxide in pediatric patients with ARDS. The study examines whether the ratio of the arterial partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) improves in a consistent fashion in patients with acute respiratory distress syndrome.


Condition Intervention Phase
ARDS
Drug: Nitric Oxide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nitric Oxide Administration for Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Improvement in paO2/FiO2 ratio. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decreased times on FiO2 [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: September 2000
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Nitric Oxide
Nitric Oxide Gas

Detailed Description:

At low concentrations, nitric oxide(NO) functions as a cellular messenger and regulator of microcirculation. NO may have an important role in the pathogenesis of ARDS as well as its treatment. The aims of the study are to attempt to show that NO will improve oxygenation as evidenced by improvement in PaO2/FiO2. With improved oxygenation, there will be decreased time on FiO2>0.60, evaluate whether the order of NO therapy will have any effect on response, and evaluate the characteristics of patients who respond to NO compared to those who do not.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is intubated and mechanically ventilated in the PICU or CICU with a P/F ration less than or equal to 100, FiO2 greater than or equal to 0.60, PEEP greater than or equal to 10, and a Murray score greater than or equal to 2.5.

Exclusion Criteria:

  • Neonates (1 week to 28 days) and/or patients on ECMO
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240487

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Rodolfo I Godinez, MD, PhD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Dr Rodolfo Godinez, The Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00240487     History of Changes
Other Study ID Numbers: 2000-9-2088
Study First Received: October 14, 2005
Last Updated: February 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Acute Respiratory Distress Syndrome
ARDS
Nitric Oxide

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
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 July 20, 2014