Temperature Control in Central Fever in the Neuro-ICU

NCT00751634 | Completed Phase 4 Results

• 1 other identifier: 1507-009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

There are few treatments for central fever (fever that is due to the central nervous system, as opposed to an infectious source). We hypothesize that an externally applied cooling blanket will reduce temperature in neurologically ill patients with central fever.

Conditions

Fever; Brain Hemorrhage

Keywords

subarachnoid hemorrhage; intracerebral hemorrhage; fever

Outcome Measures

Primary Outcomes (1)

• Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care

  Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol.

  baseline, one, two and six hours after application.

Secondary Outcomes (4)

• Time From Start of Cooling Device to Core Temperature < 100.4F

  Six hours

• Number of Participants With Severe Shivering

  six hours

• Number of Participants With Hypotension

  six hours

• Number of Participants With Arrhythmia

  Six hours

Study Arms (1)

A

EXPERIMENTAL

Application of the Gaymar Rapr-Round device per approved use

Device: Gaymar Rapr-Round (external cooling blanket)

Interventions

Gaymar Rapr-Round (external cooling blanket) DEVICE

Application of the device per its approved labeling

A

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Two or more days with core temperature ≥ 100.4F
• Approval of the patient's primary attending physician
• Need for core temperature measurement independent of the study.
• Admission to the Neuro-ICU \[intensive care unit\] for an underlying condition

You may not qualify if:

• Evidence for an infectious cause of fever, such as pneumonia, bacteremia, CNS \[central nervous system\] infection or urinary tract infection.
• Expected death from any cause
• Known sensitivity to the device
• History of pre-admission hypothalamic dysfunction or known temperature dysregulation
• Use of 2 or more vasopressor medications, since this may make a local skin reaction to the device more likely
• Hemodynamic instability

Sponsors & Collaborators

• Northwestern University: lead
• Gaymar Industries, Inc.: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Fever; Intracranial Hemorrhages; Subarachnoid Hemorrhage; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes

Results Point of Contact

• Title: Dr. Andrew Naidech
• Organization: Northwestern University

a-naidech@northwestern.edu

312-503-3335

Study Officials

• Andrew M Naidech, MD MSPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 12, 2008
• Study Start: January 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: May 6, 2013
• Results First Posted: April 9, 2012

Record last verified: 2013-04

Locations

US (1)