Trial | NCT00030121  Report issue

Title

Carperitide in Acute Respiratory Distress Syndrome (ARDS)
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Evaluation of the Safety and Efficacy of Carperitide Infusion in Patients With ARDS

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
The purpose of this study is to determine whether Carperitide is safe and effective in the management of Acute Respiratory Distress Syndrome (ARDS).
Acute respiratory distress syndrome (ARDS is a severe form of acute lung injury. ARDS is characterized by an increase in pulmonary vascular permeability resulting from a non-cardiogenic cause, leading to an increased vascular water volume, pulmonary inflammation, and severe hypoxemia. Conventional therapy for ARDS is primarily respiratory management by mechanical ventilation using positive end-expiratory pressure (PEEP). Mechanical ventilation is the major management concern in patients with ARDS, due to its higher risk of infections and morbidity. Treatment with Carperitide may reduce time on the ventilator by reducing pulmonary edema and by improving gas exchange. The results of Carperitide studies in animals and humans support the idea that the hormone will be effective in managing the acute pulmonary complications and hypoxemia seen in ARDS.
Study Started
Dec 31
1999
Last Update
Feb 20
2008
Estimate

Drug recombinant human atrial natriuretic polypeptide

Criteria 

Inclusion:

In order to participate in the study, patients must:

be 18 years or older
have an acceptable PF ratio
have adequate fluid volume
be intubated less than 7 days

Exclusion:

In order to participate in the study, patients must not meet any of the following criteria:

be moribund
be immunocompromised
have pneumonia (caused by Pneumocystis carinii)
have recieved another investigational drug or device within the last 30 days
have a Do not Resuscitate order
No Results Posted