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

Sponsor

Hospital Universitari Son Dureta (Other)

Overall Status

Terminated

CT.gov ID

NCT00622570

Collaborator

Fondo de Investigacion Sanitaria (Other)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Drug: Pentobarbital Drug: thiopental	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2002

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Pentobarbital	Drug: Pentobarbital 10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h Other Names: Nembutal(r)
Active Comparator: 2 thiopental	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 Other Names: PENTOTHAL(R)

Arm

Intervention/Treatment

Experimental: 1

Pentobarbital

Drug: Pentobarbital

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

Other Names:

Nembutal(r)

Active Comparator: 2

thiopental

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

Other Names:

PENTOTHAL(R)

Outcome Measures

Primary Outcome Measures

Intracranial pressure control [along intensive care unit stay]

Secondary Outcome Measures

Hypotension (Mean arterial blood pressure<80 mmHg) [during barbiturate treatment]
Infection [during barbiturate treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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