Subarachnoid HemorrhageSNIFNCT00890604
Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever
A study testing Stepwise normothermia protocol, Ibuprofen and Acetominophen in people with Subarachnoid Hemorrhage and Severe Traumatic Brain Injury, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Severe Traumatic Brain Injury
- What is being tested?
- Stepwise normothermia protocol, Ibuprofen and Acetominophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Temperature > 38.3 Celsius
- Meet brain injury criteria:
- Traumatic brain injury with Glasgow Coma Scale score of 8 or less
- Subarachnoid hemorrhage without vasospasm- Hunt and Hess grade III and below
- Subarachnoid hemorrhage with vasospasm
- First febrile episode
- English speaking
Who cannot join
- Skin breakdown
- Bleeding disorders
- Increased risk for clotting
- Ongoing seizure activity
- Allergy to medications used in the study
- Prisoners
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Outcomes Associated With the Application of the 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 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.
- Being tested
- Stepwise normothermia protocol, Ibuprofen, Acetominophen
- Medical subject headings
- Subarachnoid Hemorrhage, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepwise normothermia protocolOther
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.
IbuprofenDrug
It is not the intent of the study to evaluate this drug but may be provided in conjunction with the Stepwise normothermia protocol.
AcetominophenDrug
It is not the intent of the study to evaluate this drug but may be provided in conjunction with the Stepwise normothermia protocol.
| Study group | Role | What they receive |
|---|---|---|
| Standard interventions for temperature control used in protocolized, stepwise fashion | Other | Normothermia Protocol- use of standard interventions in protocolized fashion (physical cooling, antipyretics) Receives: Other: Stepwise normothermia protocol; Drug: Ibuprofen; Drug: Acetominophen |
| Standard fever management/prevention interventions used in ad hoc fashion | No intervention | standard interventions for fever prevention used in ad hoc fashion based on nurse decision making |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Coma Score
Measured: 24 hour
Secondary outcomes (2)
temperature
Measured: hourly
length of stay (intensive care, hospital)
Measured: discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Gaymar Industries, Inc.
- Responsible party
- Principal investigator, Hilaire Thompson, University of Washington
- Investigators
- Brenda Everett, Principal investigator, Harborview Injury Prevention and Research CenterRobin Hilier, Principal investigator, Harborview Injury Prevention and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890604
- Sponsor's protocol ID
- 34140
- Acronym
- SNIF
- Status last verified
- Jun 2019
- First submitted
- 28 Apr 2009
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Associated With the Application of the Normothermia Protocol in Patients With Severe Neurological Insult and Fever
- ClinicalTrials.gov ID
- NCT00890604
- Acronym / sponsor ID
- SNIF / 34140
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Gaymar Industries, Inc.
- Study start
- Jul 2009 (actual)
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard interventions for temperature control used in protocolized, stepwise fashion | Other | Other: Stepwise normothermia protocol, Drug: Ibuprofen, Drug: AcetominophenNormothermia Protocol- use of standard interventions in protocolized fashion (physical cooling, antipyretics) |
| Standard fever management/prevention interventions used in ad hoc fashion | No intervention | –standard interventions for fever prevention used in ad hoc fashion based on nurse decision making |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Temperature > 38.3 Celsius
- Meet brain injury criteria:
- First febrile episode
- English speaking
Key exclusion criteria (7 listed)
- Skin breakdown
- Bleeding disorders
- Increased risk for clotting
- Ongoing seizure activity
- Allergy to medications used in the study
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 |
|---|---|---|
| Stepwise normothermia protocolUse 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. | Other | Standard interventions for temperature control used in protocolized, stepwise fashion |
| IbuprofenIt is not the intent of the study to evaluate this drug but may be provided in conjunction with the Stepwise normothermia protocol. | Drug | Standard interventions for temperature control used in protocolized, stepwise fashion |
| AcetominophenIt is not the intent of the study to evaluate this drug but may be provided in conjunction with the Stepwise normothermia protocol. | Drug | Standard interventions for temperature control used in protocolized, stepwise fashion |
Primary outcome
Glasgow Coma Score
Time frame: 24 hour
2 secondary outcomes
temperature
Time frame: hourly
length of stay (intensive care, hospital)
Time frame: discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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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.
Brenda Everett principal investigator
Harborview Injury Prevention and Research Center
Robin Hilier principal investigator
Harborview Injury Prevention and Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepwise normothermia protocol, Ibuprofen and Acetominophen in people with Subarachnoid Hemorrhage and Severe Traumatic Brain Injury, run by University of Washington 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 7 inclusion and 7 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 30 Jan 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glasgow Coma Score (time frame: 24 hour). 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 30 Jan 2024.