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

Phase 3

Terminated

• Conditions: Traumatic Brain Injury
• Interventions: Drug: thiopental; Drug: Pentobarbital

• Registration Number: NCT00622570
• Lead Sponsor: Hospital Universitari Son Dureta

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

Not available

Study Timeline

• Study Start: 2002-05
• Status Verified: 2007-07
• Primary Completion: 2007-07
• Study Completion: 2007-12
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-22
• Last Update Submitted: 2008-02-22
• Study First Posted: 2008-02-25
• Last Update Posted: 2008-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	thiopental	thiopental
1	Pentobarbital	Pentobarbital

Primary Outcome Measures

Name	Time	Method
Intracranial pressure control	along intensive care unit stay

Secondary Outcome Measures

Name	Time	Method
Hypotension (Mean arterial blood pressure<80 mmHg)	during barbiturate treatment
Infection	during barbiturate treatment

Trial Locations

Locations (1)

Son Dureta Hospital; 🇪🇸 Palma, Balearic Island, Spain