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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00074906 |
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Date of registration:
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23/12/2003 |
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Primary sponsor: |
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Public title:
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Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)
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Scientific title:
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Venticute in Patients With Pneumonia or Aspiration of Gastric Contents Leading to Intubation, Ventilation, and Severe Oxygenation Impairment: A Randomized, Multinational, Multicenter, Parallel Group, Double Blind, Control Group Study |
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Date of first enrolment:
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November 2003 |
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Target sample size:
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1200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00074906 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Brazil
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Canada
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Chile
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Czech Republic
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Denmark
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Estonia
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Finland
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France
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Germany
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Greece
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Hungary
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Israel
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Netherlands
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New Zealand
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Poland
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Russian Federation
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Slovakia
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South Africa
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Spain
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Sweden
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Werner Seeger, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Justus-Liebig-Universität, Gießen, Germany |
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Name:
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Roger G. Spragg, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California and La Jolla Veterans Affairs Medical Center, San Diego, CA, USA |
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Name:
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Andreas Günther, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Giessen |
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Key inclusion & exclusion criteria
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Main inclusion criteria:
- Patient has been intubated due to one of the following primary pulmonary insults:
aspiration of gastric contents or pneumonia
Main exclusion criteria:
- Principal source of infection or sepsis is outside the lung
- Severe pre-existing lung disease
- Cancer metastatic to the lung or any end stage malignancy
- History of lung, liver, pancreas, small bowel, or bone marrow/stem cell
transplantation
- Patient is morbidly obese
- Patient has a diagnosis of acute necrotizing pancreatitis
Additional criteria may apply and examination by an investigator is required to determine
eligibility.
Age minimum:
12 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pneumonia
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Intervention(s)
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Drug: Venticute
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Primary Outcome(s)
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Survival on day 28
[Time Frame: 28 days]
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Secondary Outcome(s)
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How long the lung and the patient (overall) are recovering
[Time Frame: 28 days]
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Secondary ID(s)
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BY2001/M1-007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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