FeverPhase 4NCT00751634
Temperature Control in Central Fever in the Neuro-ICU
A Phase 4 study testing Gaymar Rapr-Round (external cooling blanket) in people with Fever and Brain Hemorrhage, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Fever, Brain Hemorrhage
- What is being tested?
- Gaymar Rapr-Round (external cooling blanket)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
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
- Being tested
- Gaymar Rapr-Round (external cooling blanket)
- Keywords
- subarachnoid hemorrhage, intracerebral hemorrhage, fever
- Medical subject headings
- Fever, Intracranial Hemorrhages, Subarachnoid Hemorrhage, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaymar Rapr-Round (external cooling blanket)Device
Application of the device per its approved labeling
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Application of the Gaymar Rapr-Round device per approved use Receives: Device: Gaymar Rapr-Round (external cooling blanket) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, one, two and six hours after application.
Secondary outcomes (4)
Time From Start of Cooling Device to Core Temperature < 100.4F
For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was <100.4F
Measured: Six hours
Number of Participants With Severe Shivering
Severe shivering as measured by the bedside shivering assessment scale: 0 None: no shivering noted on palpation of the masseter, neck, or chest wall
- Mild: shivering localized to the neck and/or thorax only
- Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax)
- Severe: shivering involves gross movements of the trunk and upper and lower extremities
Measured: six hours
Number of Participants With Hypotension
New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period
Measured: six hours
Number of Participants With Arrhythmia
New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm
Measured: Six hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Gaymar Industries, Inc.
- Responsible party
- Principal investigator, Andrew Naidech, Northwestern University
- Investigators
- Andrew M Naidech, MD MSPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751634
- Sponsor's protocol ID
- 1507-009
- Status last verified
- Apr 2013
- First submitted
- 10 Sep 2008
- Last updated
- 6 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature Control in Central Fever in the Neuro-ICU
- ClinicalTrials.gov ID
- NCT00751634
- Acronym / sponsor ID
- 1507-009
- Conditions
- Fever, Brain Hemorrhage
- Keywords
- subarachnoid hemorrhage, intracerebral hemorrhage, fever
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Gaymar Industries, Inc.
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Posted 9 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Gaymar Rapr-Round (external cooling blanket)Application of the Gaymar Rapr-Round device per approved use |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gaymar Rapr-Round (external cooling blanket)Application of the device per its approved labeling | Device | A |
Primary outcome
Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care
Time frame: baseline, one, two and six hours after application.
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.
4 secondary outcomes
Time From Start of Cooling Device to Core Temperature < 100.4F
Time frame: Six hours
Number of Participants With Severe Shivering
Time frame: six hours
Number of Participants With Hypotension
Time frame: six hours
Number of Participants With Arrhythmia
Time frame: Six hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Fever
Recruiting
Assessment of Communication Interventions on Vaccination Knowledge and Acceptance
Vaccination Knowledge and Acceptance, Informed Vaccine-decision Making
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew M Naidech, MD MSPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gaymar Rapr-Round (external cooling blanket) in people with Fever and Brain Hemorrhage, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care (time frame: baseline, one, two and six hours after application.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.