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Investigation of hypothermia in patients with severe brain damage

Pentobarbital Coma With Therapeutic Hypothermia versus normothermic hypothermia in patients with severe Traumatic Brain Injury: A prospective double blind controlled randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090923002496N14
Enrollment
42
Registered
2024-08-16
Start date
2024-08-02
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypothermia. Hypothermia

Interventions

Intervention group: 42 patients with severe brain damage will be included in the study, and as much as possible, in order to reduce confounding factors, people with relatively similar conditions (Glas

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ) age between 18-752) Severe brain damage3) Decreased level of consciousness (Glasgow coma score =8)4) Continuous control of body temperature5) Ethical consent from the first degree companion of the patient

Exclusion criteria

Exclusion criteria: 1) Patients who have problems in terms of surgery and have intra-visceral and mediastinal bleeding.2) head trauma patients who have parenchymal bleeding.3) Patients who have irreversible coagulopathy.4) Sepsis patients5) Lack of accompanying consent6 (Pregnant women

Design outcomes

Primary

MeasureTime frame
Improving the performance of trauma patients one month and six months after discharge. Timepoint: Upon discharge, one month after discharge, six months after discharge. Method of measurement: A total of 42 patients with severe brain injury will enter the study. To minimize confounding factors, we will place individuals with relatively similar conditions (Glasgow scores and CPC scores close to each other) into two different groups. All individuals in both groups will receive sodium thiopental at a dose of 2.5 kg/mg intravenously every 15 minutes, up to 4 doses, followed by a continuous infusion of 5 hr/kg/mg intravenously for 3 hours, and then 2 hr/kg/mg intravenously continuously. The body temperature of the first group will be maintained at normothermia (36-37 degrees Celsius), while the body temperature of the second group will be maintained at hypothermia (34-35 degrees Celsius). This will be carried out for 72-96 hours, after which we will interpret the results. During the hypothermia induction process, we must ensure the comfort and pain relief of the patients. To prevent shivering due to hypothermia, we will use analgesics (such as intravenous pethidine), sedatives, magnesium sulfate intravenously at a dose of 4 grams daily, and non-depolarizing muscle relaxants. Patient assessments will be conducted using the CPC Scale (Cerebral Performance Categories Scale).Blood cultures in these patients are necessary due to the use of phenobarbital and the potential immunosuppression it causes, to check for microbial infections. Routine blood tests for TSH, FT4, T3, T4, and vitamin D, B levels, along with CBC and UA/C, will be performed daily. Information regarding the nutritional factors and supplements received by patients during their hospital stay will be recorded. In this study, the body mass index (BMI) will be estimated for all patients under study, along with serum albumin levels and those vitamins and minerals identified through routine hospital tests.It is impor

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHassan Soleimanpour

Tabriz University of Medical Sciences

soleimanpourh@tbzmed.ac.ir+98 41 3335 2078

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026