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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2007-12-31

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.

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Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Pentobarbital

Group Type EXPERIMENTAL

Pentobarbital

Intervention Type DRUG

10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h

2

thiopental

Group Type ACTIVE_COMPARATOR

thiopental

Intervention Type DRUG

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

Interventions

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Pentobarbital

10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h

Intervention Type DRUG

thiopental

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

Intervention Type DRUG

Other Intervention Names

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Nembutal(r) PENTOTHAL(R)

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

Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No