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NCT00890604 · ClinicalTrials.gov registry record · NA

Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever

A NA study, sponsored by University of Washington.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT00890604: Completed NA study, sponsored by University of Washington.

NCT00890604 is a NA study that has completed, run by University of Washington. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00890604, a NA study, has completed, sponsored by University of Washington.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

When fever is present in patients with stroke, traumatic brain injury (TBI), or brain hemorrhage, it has been associated with worse outcomes including larger areas of tissue death, increased length of stay, worse degree of coma, lower ability to function, and higher mortality. Both adult and pediatric TBI national guidelines state that maintenance of normal body temperature should be a standard of care. However, no further standards or options are presented to specifically guide practice. The current ischemic stroke guidelines state that fever should be treated with fever-reducing agents and offer "cooling devices" as an option but do not provide specifics to guide practice. Over 50% of patients in the Neurosurgical Intensive Care Unit (ICU) at Harborview Medical Center develop fever during the course of their stay. With elevated temperatures the body consumes more oxygen than if the temperature was normal, causing less oxygen to be available to the brain. This may lead to injury of the brain cells and a diminished capacity for healing. Thus, temperature management in neurologically vulnerable patients is both a prevalent and problematic challenge. Based on this information the goal of the present proposal is to evaluate if 1) A standardized, step-wise approach to temperature management using a Normothermia Protocol is successful in achieving and maintaining normal temperature in Neurosurgical ICU patients; and 2) If maintenance of normal temperature will be associated with fewer episodes of diminished responsiveness in their neurological exams as evidenced by a measure of depth of coma, as measured by the Glasgow Coma Score (GCS) compared to a control group treated according to usual care.

Interventions

  • DRUG Ibuprofen
  • DRUG Acetominophen
  • OTHER Stepwise normothermia protocol

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2009-07
Est. Completion 2011-07
Phase NA
University of Washington

1,048 total trials

What the finished NCT00890604 record still lists

NCT00890604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 3 interventions - of which Ibuprofen is the first listed.

NCT00890604 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00890604 about?

NCT00890604 is a clinical study titled "Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever". When fever is present in patients with stroke, traumatic brain injury (TBI), or brain hemorrhage, it has been associated with worse outcomes including larger areas of tissue death, increased length of stay, worse degree of coma, lower ability to function, and higher mortality. Both adult and pediatr...

What is the current status of trial NCT00890604?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2009-07. Estimated completion is 2011-07.

What interventions are being tested in trial NCT00890604?

The interventions under investigation include: Ibuprofen (DRUG), Acetominophen (DRUG), Stepwise normothermia protocol (OTHER).

Who is sponsoring clinical trial NCT00890604?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00890604's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00890604, the US trial registry maintained by the National Library of Medicine. NCT00890604 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.