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

Protocol summary

Study aim
Reducing mortality and complications in patients with severe brain injuries
Design
Clinical trial with control and intervention groups with parallel groups, single-blind, randomized on 42 patients
Settings and conduct
42 patients with severe brain damage will be included in the study, and in order to reduce confounding factors as much as possible, we will put people with relatively similar conditions (Glasgow and CPC scores close to each other) into two different groups. We inject a dose of 2.5 mg/kg intravenously every 15 minutes and up to 4 doses, and then we inject 5 mg/kg/hr intravenously for 3 hours and then continuously inject 2 mg/kg/hr intravenously to the patients. Body temperature We put the first group in a thermothermic state (36-37°C) and the second group's body temperature in a hypothermic state (34-35°C). We do this for 72-96 hours and then the results We interpret.
Participants/Inclusion and exclusion criteria
Target population: Patients with severe brain damage who are hospitalized in the intensive care unit. Inclusion criteria: 1) Age between 18-75 2) Severe brain damage 3) Decreased level of consciousness (Glasgow coma score ≤8) 4) Continuous control of body temperature 5) Ethical consent from the first degree companion of the patient Exit 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 patients 5) lack of accompanying consent 6) Pregnant women
Intervention groups
We put the body temperature of the first group in the normothermic state (36-37 degrees Celsius) and the second group's body temperature in the hypothermic state (34-35 degrees Celsius).
Main outcome variables
Improving the performance of trauma patients one month and six months after discharge

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090923002496N14
Registration date: 2024-08-16, 1403/05/26
Registration timing: registered_while_recruiting

Last update: 2024-08-16, 1403/05/26
Update count: 0
Registration date
2024-08-16, 1403/05/26
Registrant information
Name
Hassan Soleimanpour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1329 1286
Email address
soleimanpourh@tbzmed.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-02, 1403/05/12
Expected recruitment end date
2025-08-05, 1404/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pentobarbital Coma With Therapeutic Hypothermia versus normothermic hypothermia in patients with severe Traumatic Brain Injury: A prospective double blind controlled randomized clinical trial
Public title
Investigation of hypothermia in patients with severe brain damage
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 42
More than 1 sample in each individual
Number of samples in each individual: 21
42 patients with severe brain damage will be included in the study, and as much as possible, in order to reduce confounding factors, we will put people with relatively similar conditions (Glasgow and CPC scores close to each other) into two different groups. We inject a dose of 2.5 mg/kg intravenously every 15 minutes and up to 4 doses, and then we inject 5 mg/kg/hr intravenously for 3 hours and then 2 mg/kg/hr intravenously continuously to the patients. Body temperature We put the first group in a thermothermic state (36-37°C) and the second group's body temperature in a hypothermic state (34-35°C). We do this for 72-96 hours and then the results We interpret.
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: each patient is randomly assigned with equal probability to one of the two groups of mild hypothermia or normothermia with barbiturate coma. The randomization unit in this study is an individual; This means that each patient is assigned to one of the study groups independently and separately. Patients are placed in different strata based on specific variables such as age, gender, and severity of brain damage (based on the Glasgow scale) and then randomly assigned to study groups in each stratum. - Statistical software: R software is used to generate random sequences. In R software, functions such as sample() are used to generate a random allocation list.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are not aware of the group to which they are assigned. This does not mean that patients are unaware of participating in the study, but they are unaware of the details of the interventions used.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Approval date
2024-07-08, 1403/04/18
Ethics committee reference number
IR.TBZMED.REC.1403.266

Health conditions studied

1

Description of health condition studied
hypothermia
ICD-10 code
T68
ICD-10 code description
Hypothermia

Primary outcomes

1

Description
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 important that at-risk patients are identified by assessing their nutritional status within 48 hours of hospital admission. Various scoring tools will be used to evaluate nutritional risks, including physical examination, dietary intake, functional assessment, disease severity, and anthropometric data. However, most of these tools do not consider nutritional assessment criteria, inflammatory processes, and hypermetabolic/muscle status. To assess the nutritional status of patients admitted to the Intensive Care Unit (ICU), the NUTRIC scale will also be used. This scale includes 6 variables with scores ranging from zero to ten. Scores above 6 indicate high nutritional risk for the patient. The variables in this scale include age, disease severity based on acute physiology and chronic health evaluation scores (APACHE II), and sequential organ failure assessment (SOFA) scores at admission, the number of comorbidities, length of stay (LOS) before transfer to the ICU, and levels of interleukin 6 (IL-6). If the IL-6 levels are not available, the modified NUTRIC scale will be used, which includes all the aforementioned variables except for IL-6 levels. In this scale, scores less than or equal to 4 indicate low nutritional risk. For patients admitted to the ICU, APACHE II and SOFA scores are measured and available upon admission. The modified scale will be calculated within 46 hours after admission to the ICU.Information regarding nutritional factors and supplements received by patients during their hospital stay will be analyzed in relation to mortality, length of stay, need for mechanical ventilation, and patient status during a 6-month follow-up. Changes in CT scans of patients will be assessed before the start of the research process, during the study, and after the study's completion. Levels of CPK enzymes and superoxide dismutase will be measured and analyzed. Additionally, the MoCA will be used to assess personality disorders and memory.

Secondary outcomes

empty

Intervention groups

1

Description
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 (Glasgow and CPC scores are close to each other) will be placed in two different groups. We inject sodium thiopental with a dose of 2.5 kg/mg intravenously every 15 minutes and up to 4 doses, and then we inject 5 hr/kg/mg intravenously for 3 hours and then 2 hr/kg/mg intravenously to the patients continuously. We put the body temperature of the intervention group in hypothermia (34-35 degrees Celsius). We do this for 72-96 hours and then interpret the results.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Dr.Hassan Soleimanpour
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
تبریز
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
soleimanpourh@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7310
Email
shahabip@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
soleimanpourh@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
soleimanpourh@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
soleimanpourh@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All individual data from the study will be accessible after de-identification.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
En Data will be available for all interested researchers.
Under which criteria data/document could be used
Data will be available for all interested researchers.
From where data/document is obtainable
Data will be available for use in other studies. researchers can ask for data of this study by sending email to dr. Hassan Soleimanpour. soleimanpourh@tbzmed.ac.ir
What processes are involved for a request to access data/document
By sending an e-mail request, the documents can be received within a period of about two weeks.
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