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

Last updated: February 22, 2008
Sponsor: Hospital Universitari Son Dureta
Overall Status: Terminated

Phase

3

Condition

Traumatic Brain Injury

Stress

Memory Loss

Treatment

N/A

Clinical Study ID

NCT00622570
PI 02/0642
IB
  • Ages 15-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 BTFguidelines (1)

  • Hemodynamic stability defined as a systolic blood pressure of at least 100 mm Hg orabove at the moment of entering the trial

  • Written informed consent obtained from next-of-kin or the patient's legally authorizedrepresentative

Exclusion

Exclusion Criteria:

  • Previously known ischemic heart failure (Ejection fraction < 35%)

  • Pregnancy

  • bilateral dilated and unreactive pupils and a GCS of 3

  • Intolerance to barbiturates

Study Design

Total Participants: 44
Study Start date:
May 01, 2002
Estimated Completion Date:
December 31, 2007

Connect with a study center

  • Son Dureta Hospital

    Palma, Balearic Island 07014
    Spain

    Site Not Available

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