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

Tracking Information

First Received Date ^ICMJE

February 14, 2008

Last Updated Date

February 22, 2008

Start Date ^ICMJE

May 2002

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00622570 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Traumatic Brain Injury

Intervention ^ICMJE

Drug: Pentobarbital
Drug: thiopental

Study Arms / Comparison Groups

Experimental: Pentobarbital
Active Comparator: thiopental

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

15 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT ID ^ICMJE

NCT00622570

Responsible Party

Dr. Jon Pérez Bárcena, Hospital Son Dureta

Study ID Numbers ^ICMJE

PI 02/0642, IB

Study Sponsor ^ICMJE

Hospital Universitari Son Dureta

Collaborators ^ICMJE

Fondo de Investigacion Sanitaria

Investigators ^ICMJE

Principal Investigator:

Jon Perez, MD

Son Dureta Hospital

Information Provided By

Hospital Universitari Son Dureta

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP