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).
Respiratory Distress Syndrome
Drug: recombinant human atrial natriuretic polypeptide
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official 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|
|Study Start Date:||December 1999|
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.