Phase 4
Completed N=20
Temperature Control in Central Fever in the Neuro-ICU
Fever · Brain Hemorrhage
Source: ClinicalTrials.gov NCT00751634 ↗
Enrolled (actual)
20
Serious AEs
20.0%
Results posted
Apr 2012
Primary outcomePrimary: Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care — 100.8; 100.3; 99.9; 99.5 degrees F
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care |
100.8; 100.3; 99.9; 99.5 | — |
| SECONDARY Time From Start of Cooling Device to Core Temperature < 100.4F |
2.1 | — |
| SECONDARY Number of Participants With Severe Shivering |
4 | — |
| SECONDARY Number of Participants With Hypotension |
— | — |
| SECONDARY Number of Participants With Arrhythmia |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00751634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.