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

Primary Purpose

Traumatic Brain Injury

Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Pentobarbital
thiopental
Sponsored by
Hospital Universitari Son Dureta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic brain injury, barbiturate coma

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Son Dureta Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Pentobarbital

thiopental

Outcomes

Primary Outcome Measures

Intracranial pressure control

Secondary Outcome Measures

Hypotension (Mean arterial blood pressure<80 mmHg)
Infection

Full Information

First Posted
February 14, 2008
Last Updated
February 22, 2008
Sponsor
Hospital Universitari Son Dureta
Collaborators
Fondo de Investigacion Sanitaria
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1. Study Identification

Unique Protocol Identification Number
NCT00622570
Brief Title
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

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Terminated
Why Stopped
Slowly recruitment rate. Intermediate analysis
Study Start Date
May 2002 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitari Son Dureta
Collaborators
Fondo de Investigacion Sanitaria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic brain injury, barbiturate coma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Pentobarbital
Arm Title
2
Arm Type
Active Comparator
Arm Description
thiopental
Intervention Type
Drug
Intervention Name(s)
Pentobarbital
Other Intervention Name(s)
Nembutal(r)
Intervention Description
10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h
Intervention Type
Drug
Intervention Name(s)
thiopental
Other Intervention Name(s)
PENTOTHAL(R)
Intervention Description
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
Primary Outcome Measure Information:
Title
Intracranial pressure control
Time Frame
along intensive care unit stay
Secondary Outcome Measure Information:
Title
Hypotension (Mean arterial blood pressure<80 mmHg)
Time Frame
during barbiturate treatment
Title
Infection
Time Frame
during barbiturate treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Perez, MD
Organizational Affiliation
Son Dureta Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Son Dureta Hospital
City
Palma
State/Province
Balearic Island
ZIP/Postal Code
07014
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
15756405
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.
Results Reference
result
PubMed Identifier
18759980
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.
Results Reference
derived

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

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