NCT Number: NCT00030121
Carperitide in Acute Respiratory Distress Syndrome (ARDS)
The purpose of this study is to determine whether Carperitide is safe and effective in the management of Acute Respiratory Distress Syndrome (ARDS).
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Suntory Pharmaceutical
Industry
Registry information
Official study title
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
Important dates
- Study start
- 1999
- First posted
- Feb 1, 2002
- Registry last updated
- Feb 20, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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