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

February 22, 2008 updated by: Hospital Universitari Son Dureta

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Balearic Island
      • Palma, Balearic Island, Spain, 07014
        • Son Dureta Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 71 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intracranial pressure control
Time Frame: along intensive care unit stay
along intensive care unit stay

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Son Dureta

Collaborators

Fondo de Investigacion Sanitaria

Investigators

  • Principal Investigator: Jon Perez, MD, Son Dureta Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 22, 2008

First Posted (Estimate)

February 25, 2008

Study Record Updates

Last Update Posted (Estimate)

February 25, 2008

Last Update Submitted That Met QC Criteria

February 22, 2008

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI 02/0642
  • IB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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