Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension

Study Overview
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Brief Summary
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Objective: to assess the effectiveness of pentobarbital and thiopental to control raised intracranial pressure (ICP), refractory to first level measures, in patients with severe traumatic brain injury. Material and methods: prospective, randomized open study to compare the effectiveness between two treatments: pentobarbital and thiopental. The patients will be selected from those admitted to the Intensive Care Unit with a severe traumatic brain injury (postresuscitation Glasgow Coma Scale equal or less than 8 points) and raised ICP (ICP>20 mmHg) refractory to first level measures according to the Brain Trauma Foundation guidelines. The adverse effects of both treatments were also collected.

Official Title
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Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension.

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Drug: Pentobarbital
* Drug: thiopental


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a severe closed head injury and a post-resuscitation Glasgow Coma Scale (GCS) score below or equal to 8 Age between 15 and 76 years (inclusive) High ICP (> 20 mm Hg) refractory to first-tier therapeutic measures according to BTF guidelines (1) Hemodynamic stability defined as a systolic blood pressure of at least 100 mm Hg or above at the moment of entering the trial Written informed consent obtained from next-of-kin or the patient's legally authorized representative Exclusion Criteria: Previously known ischemic heart failure (Ejection fraction < 35%) Pregnancy bilateral dilated and unreactive pupils and a GCS of 3 Intolerance to barbiturates

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pentobarbital | Drug: Pentobarbital<br>* 10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h<br>* Other names: Nembutal(r);|
| Active Comparator: 2<br>thiopental | Drug: thiopental<br>* 2 mg/kg in bolus; if ICP is not below 20 mmHg then 3 mg/kg in bolus; if ICP is not below 20 mmHg it can be administrated a third bolus of 5 mg/kg. Maintenance: 3 mg/kg/h in perfusion<br>* Other names: PENTOTHAL(R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracranial pressure control |  | along intensive care unit stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension (Mean arterial blood pressure<80 mmHg) |  | during barbiturate treatment | 
| Infection |  | during barbiturate treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury, barbiturate coma