Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension
Information source: Hospital Universitari Son Dureta
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Traumatic Brain Injury
Intervention: Pentobarbital (Drug); thiopental (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Hospital Universitari Son Dureta Official(s) and/or principal investigator(s):
Jon Perez, MD, Principal Investigator, Affiliation: Son Dureta Hospital
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.
Clinical Details
Official title: Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Intracranial pressure control
Secondary outcome: Hypotension (Mean arterial blood pressure<80 mmHg)Infection
Eligibility
Minimum age: 15 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Son Dureta Hospital, Palma, Balearic Island 07014, Spain
Additional Information
Starting date: May 2002
Last updated: February 22, 2008
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