Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension - Full Text View

Sponsor:	Hospital Universitari Son Dureta
Collaborator:	Fondo de Investigacion Sanitaria
Information provided by:	Hospital Universitari Son Dureta
ClinicalTrials.gov Identifier:	NCT00622570

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension.

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Traumatic Brain Injury

Drug Information available for: Pentobarbital sodium Thiopental sodium Pentobarbital Thiopental

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
1: Experimental Pentobarbital	Drug: Pentobarbital 10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h
2: Active Comparator 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

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, Balearic Island
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:

Pérez-Bárcena J, Barceló B, Homar J, Abadal JM, Molina FJ, de la Peña A, Sahuquillo J, Ibáñez J. [Comparison of the effectiveness of pentobarbital and thiopental in patients with refractory intracranial hypertension. Preliminary report of 20 patients] Neurocirugia (Astur). 2005 Feb;16(1):5-12; discussion 12-3. Spanish.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Pérez-Bárcena J, Llompart-Pou JA, Homar J, Abadal JM, Raurich JM, Frontera G, Brell M, Ibáñez J, Ibáñez J. Pentobarbital versus thiopental in the treatment of refractory intracranial hypertension in patients with traumatic brain injury: a randomized controlled trial. Crit Care. 2008;12(4):R112. Epub 2008 Aug 29.

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

Keywords provided by Hospital Universitari Son Dureta:

Traumatic brain injury, barbiturate coma

Additional relevant MeSH terms:

Craniocerebral Trauma
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Thiopental
GABA Modulators
Physiological Effects of Drugs
Anesthetics
Disorders of Environmental Origin
Brain Diseases
Intracranial Hypertension
Pentobarbital
Therapeutic Uses
Hypnotics and Sedatives
Cardiovascular Diseases
Brain Injuries

Anesthetics, Intravenous
Nervous System Diseases
Wounds and Injuries
Vascular Diseases
Pseudotumor Cerebri
Central Nervous System Diseases
Central Nervous System Depressants
Trauma, Nervous System
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
GABA Agents
Central Nervous System Agents
Anticonvulsants
Hypertension

ClinicalTrials.gov processed this record on November 09, 2009