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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
History of Changes

October 14, 2005
February 10, 2009
September 2000
September 2008   (final data collection date for primary outcome measure)
Improvement in paO2/FiO2 ratio. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00240487 on ClinicalTrials.gov Archive Site
Decreased times on FiO2 [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Nitric Oxide Administration for Acute Respiratory Distress Syndrome
Nitric Oxide Administration for Acute Respiratory Distress Syndrome

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
ARDS
Drug: Nitric Oxide
Nitric Oxide Gas
Active Comparator: 1
Intervention: Drug: Nitric Oxide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
1 Month to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00240487
2000-9-2088
No
Dr Rodolfo Godinez, The Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Not Provided
Principal Investigator: Rodolfo I Godinez, MD, PhD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP