Calfactant for Direct Acute Respiratory Distress Syndrome
Summary
This study will determine if administration of an suspension of calfactant, a lung surfactant, intratracheally in patients with Direct Acute Respiratory Distress Syndrome within 48 hours of requiring mechanical ventilation can decrease the mortality in patients with lethal disease and shorten the course of respiratory failure in patients with sub-lethal disease.
Description
Recruitment limited to direct adult respiratory distress syndrome patients who have been intubated <48 hours. Origin of ARDS must be infectious pneumonia, aspiration of stomach contents, near drowning, smoke inhalation without pulmonary burn, inhaled industrial gas.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Respiratory Distress Syndrome, Adult
Intervention
Calfactant, Room Air (placebo)
Location
University of Florida
Gainesville
Florida
United States
68198
Status
Terminated
Source
Pneuma Pharmaceuticals Incorporated
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00682500
- Information obtained from ClinicalTrials.gov on August 20, 2012
Medical and Biotech [MESH] Definitions
Respiratory Distress Syndrome, Adult
A syndrome characterized by progressive life-threatening RESPIRATORY INSUFFICIENCY in the absence of known LUNG DISEASES, usually following a systemic insult such as surgery or major TRAUMA.
Bronchopulmonary Dysplasia
A chronic lung disease developed after OXYGEN INHALATION THERAPY or mechanical ventilation (VENTILATION, MECHANICAL) usually occurring in certain premature infants (INFANT, PREMATURE) or newborn infants with respiratory distress syndrome (RESPIRATORY DISTRESS SYNDROME, NEWBORN). Histologically, it is characterized by the unusual abnormalities of the bronchioles, such as METAPLASIA, decrease in alveolar number, and formation of CYSTS.
Respiratory Syncytial Virus, Bovine
A species of PNEUMOVIRUS causing an important respiratory infection in cattle. Symptoms include fever, conjunctivitis, and respiratory distress.
Hyaline Membrane Disease
A respiratory distress syndrome in newborn infants, usually premature infants with insufficient PULMONARY SURFACTANTS. The disease is characterized by the formation of a HYALINE-like membrane lining the terminal respiratory airspaces (PULMONARY ALVEOLI) and subsequent collapse of the lung (PULMONARY ATELECTASIS).
Porcine Reproductive And Respiratory Syndrome
A syndrome characterized by outbreaks of late term abortions, high numbers of stillbirths and mummified or weak newborn piglets, and respiratory disease in young unweaned and weaned pigs. It is caused by PORCINE RESPIRATORY AND REPRODUCTIVE SYNDROME VIRUS. (Radostits et al., Veterinary Medicine, 8th ed, p1048)
Clinical Trials
Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome
The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of...
Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
The purpose of this study is to assess innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS.
A Randomized Trial of GM-CSF in Patients With ALI/ARDS
This study will test the hypothesis that administration of granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with acute lung injury/acute respiratory distress syndrome...
The objective of this study is to analyze by trans-oesophageal echocardiography the effect on the right ventricle of positive expiratory pressure (PEP) level variations with constant plate...
Understanding the role VEGF plays in ARDS consequently provides an ideal opportunity to discover new therapies for ARDS.
PubMed Articles
Chickenpox: a cause of acute respiratory distress syndrome to bear in mind.
The authors report a case of chickenpox (varicella) in an adult, complicated by acute respiratory distress syndrome and resulting in death.
Abstract Context.-Both nuclear factor κB and Fos-related antigen 1 have been implicated in the pathogenesis of inflammatory lung diseases, including acute lung injury/acute respiratory distress syndr...
The role of neuromuscular blocking drugs in early severe acute respiratory distress syndrome.
BACKGROUND: Acute respiratory distress syndrome (ARDS) is defined as severe hypoxemic respiratory failure resulting from diffuse lung injury and secondary to direct and indirect...
Functional disability 5 years after acute respiratory distress syndrome.
There have been few detailed, in-person interviews and examinations to obtain follow-up data on 5-year outcomes among survivors of the acute respiratory distress syndrome (ARDS).
