Nitric Oxide Administration for Acute Respiratory Distress Syndrome

April 23, 2015 updated by: Children's Hospital of Philadelphia
This research project is an open-label, randomized study for the use of Nitric Oxide in pediatric patients with acute respiratory distress syndrome (ARDS). The study examines whether nitric oxide (NO) treatment impacts the the P:F ratio (arterial partial pressure of oxygen (PaO2) divided by fraction of inspired oxygen (FiO2) in patients with ARDS. The goal of the study is to 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. NO may be primarily useful in improving matching of ventilation and perfusion in the lung. The aims of the study are to attempt to show that NO will improve oxygenation as evidenced by improvement in PaO2/FiO2. Secondary aims are to see if the improvement in oxygenation allows there to 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.

Subjects will be randomized to receive either nitric oxide first (nitric oxide for the first 4 hours, then no intervention/no nitric oxide for the next 4 hours) or delayed treatment with nitric oxide (no intervention/no nitric oxide for the first 4 hours, then nitric oxide for the next 4 hours)..

Blood gases were monitored once an hour during study participation (total of 8 hours). Final PaO2/FiO2 levels will be compared after 8 hours of study treatment in each group.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is intubated and mechanically ventilated in the Pediatric Intensive Care Unit with a PaO2/FiO2 ratio 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 extracorporeal membrane oxygenation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nitric oxide first
Subjects will be randomized to receive Nitric Oxide (NO) immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases will be monitored once an hour for 4 hours. After the first 4 hours of study participation, the nitric oxide (NO) will be turned off and subjects will receive no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects will receive standard clinical are. Blood gases will be monitored once an hour for 4 hours.
Drug: Nitric Oxide
Subjects will receive inhaled Nitric Oxide at a dose of 10 parts per million (ppm) for a 4 hour study period. Blood gases will be collected once an hour.
Other Names:
  • Inhaled Nitric Oxide
Other: No Intervention
Subjects will receive no intervention (i.e., no nitric oxide treatment) for a 4 hour study period. Blood gases will be collected once an hour. During this time, all subjects will receive standard clinical care.
Active Comparator: Delayed nitric oxide
Subjects will be randomized to receive no intervention (no nitric oxide) for he first 4 hours of study participation. During this time, all subjects will receive standard clinical care. Blood gases will be monitored once an hour for 4 hours. After the first 4 hours of study participation, the nitric oxide will be turned on and subjects will receive 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases will be monitored once an hour for 4 hours.
Drug: Nitric Oxide
Subjects will receive inhaled Nitric Oxide at a dose of 10 parts per million (ppm) for a 4 hour study period. Blood gases will be collected once an hour.
Other Names:
  • Inhaled Nitric Oxide
Other: No Intervention
Subjects will receive no intervention (i.e., no nitric oxide treatment) for a 4 hour study period. Blood gases will be collected once an hour. During this time, all subjects will receive standard clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean PaO2/FiO2 Ratio
Time Frame: 8 hours
Arterial blood gas measurements with cooximetry to evaluate arterial partial pressure of oxygen (PaO2) and fraction of inspired oxygen (FiO2) ratio. The mean PaO2/FiO2 ratio for each group after completion 8 hour of study participation was compared
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

Mallinckrodt

Investigators

  • Principal Investigator: Rodolfo I Godinez, MD, PhD, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

October 14, 2005

First Submitted That Met QC Criteria

October 14, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

April 24, 2015

Last Update Submitted That Met QC Criteria

April 23, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000-9-2088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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