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Safety Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS)

NCT02425579 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-10-17

No results posted yet for this study

Summary

The purpose of this study is to assess the safety of inhaled carbon monoxide (iCO) in intubated patients with sepsis-induced ARDS.

Conditions

  • Acute Respiratory Distress Syndrome (ARDS)

Interventions

DRUG

Inhaled Carbon Monoxide at 100ppm (4 participants)

Inhaled Carbon Monoxide at 100ppm for up to 90 minutes daily for 5 days

DRUG

Placebo for Inhaled Carbon Monoxide at 100ppm (2 participants)

Inhaled Medical Air for up to 90 minutes daily for 5 days

DRUG

Inhaled Carbon Monoxide at 200ppm (4 participants)

Inhaled Carbon Monoxide at 200ppm for 90 minutes daily for 5 days

DRUG

Placebo for Inhaled Carbon Monoxide at 200ppm (2 participants)

Inhaled Medical Air for up to 90 minutes daily for 5 days

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Laura E Fredenburgh, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02425579 on ClinicalTrials.gov