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

This study has been terminated.
(Slowly recruitment rate. Intermediate analysis)
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Universitari Son Dureta
ClinicalTrials.gov Identifier:
NCT00622570
First received: February 14, 2008
Last updated: February 22, 2008
Last verified: July 2007
History of Changes
  Purpose

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 Intervention Phase
Traumatic Brain Injury
 Drug: Pentobarbital
Drug: thiopental
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Universitari Son Dureta:

Primary Outcome Measures:
  • Intracranial pressure control [ Time Frame: along intensive care unit stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hypotension (Mean arterial blood pressure<80 mmHg) [ Time Frame: during barbiturate treatment ] [ Designated as safety issue: Yes ]
  • Infection [ Time Frame: during barbiturate treatment ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: May 2002
Study Completion Date: December 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: PENTOTHAL(R)

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622570

Locations
Spain
Son Dureta Hospital
Palma, Balearic Island, Spain, 07014
Sponsors and Collaborators
Hospital Universitari Son Dureta
Fondo de Investigacion Sanitaria
Investigators
Principal Investigator: Jon Perez, MD Son Dureta Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Jon Pérez Bárcena, Hospital Son Dureta
ClinicalTrials.gov Identifier: NCT00622570     History of Changes
Other Study ID Numbers: PI 02/0642, IB
Study First Received: February 14, 2008
Last Updated: February 22, 2008
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari Son Dureta:
Traumatic brain injury, barbiturate coma

Additional relevant MeSH terms:
Hypertension
Intracranial Hypertension
Brain Injuries
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pentobarbital
Thiopental
Adjuvants, Anesthesia
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticonvulsants

ClinicalTrials.gov processed this record on May 22, 2013