Ibuprofen in Sepsis Study

This study has been completed.

First Received on October 27, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000574

Purpose

To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.

Condition	Intervention	Phase
Acute Respiratory Distress Syndrome Lung Diseases Shock, Septic	Drug: ibuprofen	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Sepsis Shock

Drug Information available for: Ibuprofen

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:	September 1990
Estimated Study Completion Date:	July 1995

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Men and women patients with known or suspected sites of serious infection if core temperature was 38.3 degrees Celsius, heart rate 90 in the absence of beta-blockers, respiratory rate 20 or minute ventilation 10 liters per minute. In addition, one o

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000574

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigator:

Gordon Bernard

Vanderbilt University

More Information

Publications:

Bernard GR, Wheeler AP, Russell JA, Schein R, Summer WR, Steinberg KP, Fulkerson WJ, Wright PE, Christman BW, Dupont WD, Higgins SB, Swindell BB. The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group. N Engl J Med. 1997 Mar 27;336(13):912-8.

ClinicalTrials.gov Identifier:	NCT00000574 History of Changes
Other Study ID Numbers:	212
Study First Received:	October 27, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Lung Diseases
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Shock, Septic
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

Shock
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012