Harborview Medical Center
Seattle, Washington, 98104, United States
NCT Number: NCT00890604
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.
Looking for future studies?
Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Seattle, Washington, 98104, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of standard care interventions in a protocolized/step-wise fashion instead of ad hoc based on nurse decision making which may include antipyretics, physical cooling measures.
It is not the intent of the study to evaluate this drug but may be provided in conjunction with the Stepwise normothermia protocol.
It is not the intent of the study to evaluate this drug but may be provided in conjunction with the Stepwise normothermia protocol.
Time frame: 24 hour
Time frame: hourly
Time frame: discharge
University of Washington
Other
Outcomes Associated With the Application of the Normothermia Protocol in Patients With Severe Neurological Insult and Fever
Acronym: SNIF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07115459
Acute Brain Injury Coma, Brain Diseases
View Trial DetailsNCT06101537
Brain Diseases, Brain Injuries
Beijing, Beijing Municipality, China
View Trial DetailsNCT04548596
Brain Diseases, Brain Injuries
Davis, California, United States
View Trial DetailsNCT06067750
Acute Ischemic Stroke, Brain Diseases
Nottingham, Nottinghamshire, United Kingdom
View Trial Details