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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00622570
• Other study ID #: PI 02/0642
• Secondary ID: IB
• Status: Terminated
• Phase: Phase 3
• First received: February 14, 2008
• Last updated: February 22, 2008
• Start date: May 2002
• Est. completion date: December 2007

Study information

• Verified date: July 2007
• Source: Hospital Universitari Son Dureta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: December 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Intracranial Hypertension
• Traumatic Brain Injury

Intervention

Drug:
• Pentobarbital
10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h
• 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

Locations

Country	Name	City	State
Spain	Son Dureta Hospital	Palma	Balearic Island

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Son Dureta	Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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]. Ne — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial pressure control		along intensive care unit stay	No
Secondary	Hypotension (Mean arterial blood pressure<80 mmHg)		during barbiturate treatment	Yes
Secondary	Infection		during barbiturate treatment	Yes