NCT00000574

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 1990

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1990

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 1995

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

First QC Date

October 27, 1999

Last Update Submit

January 28, 2016

Conditions

Acute Respiratory Distress SyndromeLung DiseasesShock, Septic

Interventions

ibuprofenDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

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Sponsors & Collaborators

Related Publications (1)

  • 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. doi: 10.1056/NEJM199703273361303.

    PMID: 9070471BACKGROUND

MeSH Terms

Conditions

Respiratory Distress SyndromeLung DiseasesShock, Septic

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesRespiration DisordersSepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Gordon Bernard

    Vanderbilt University

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

September 1, 1990

Study Completion

July 1, 1995

Last Updated

February 1, 2016

Record last verified: 2016-01