Clinical trial NCT00622570: Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension
Official title: Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Traumatic Brain Injury
Keywords: Traumatic brain injury, barbiturate coma
Lead sponsor: Hospital Universitari Son Dureta
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
First posted: 2008-02-25
Enrollment: 44
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Intracranial pressure control
timeFrame: along intensive care unit stay
Secondary outcomes:
measure: Hypotension (Mean arterial blood pressure<80 mmHg)
timeFrame: during barbiturate treatment
measure: Infection
timeFrame: during barbiturate treatment
Other outcomes:
Locations:
city: Palma
country: Spain
facility: Son Dureta Hospital
state: Balearic Island
Study officials:
affiliation: Son Dureta Hospital
name: Jon Perez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perez-Barcena J, Barcelo B, Homar J, Abadal JM, Molina FJ, de la Pena A, Sahuquillo J, Ibanez 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.
citation: Perez-Barcena J, Llompart-Pou JA, Homar J, Abadal JM, Raurich JM, Frontera G, Brell M, Ibanez J, Ibanez 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. doi: 10.1186/cc6999. Epub 2008 Aug 29.