NCT00622570

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2002

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed
Last Updated

February 25, 2008

Status Verified

July 1, 2007

Enrollment Period

5.2 years

First QC Date

February 14, 2008

Last Update Submit

February 22, 2008

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury, barbiturate coma

Outcome Measures

Primary Outcomes (1)

  • Intracranial pressure control

    along intensive care unit stay

Secondary Outcomes (2)

  • Hypotension (Mean arterial blood pressure<80 mmHg)

    during barbiturate treatment

  • Infection

    during barbiturate treatment

Study Arms (2)

1

EXPERIMENTAL

Pentobarbital

Drug: Pentobarbital

2

ACTIVE COMPARATOR

thiopental

Drug: thiopental

Interventions

PentobarbitalDRUG

10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h

Also known as: Nembutal(r)
1
thiopentalDRUG

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

Also known as: PENTOTHAL(R)
2

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previously known ischemic heart failure (Ejection fraction \< 35%)
  • Pregnancy
  • bilateral dilated and unreactive pupils and a GCS of 3
  • Intolerance to barbiturates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Son Dureta Hospital

Palma, Balearic Island, 07014, Spain

Location

Related Publications (2)

  • 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.

    PMID: 15756405RESULT

  • 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.

    PMID: 18759980DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

PentobarbitalThiopental

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

BarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiobarbiturates

Study Officials

  • Jon Perez, MD

    Son Dureta Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 25, 2008

Study Start

May 1, 2002

Primary Completion

July 1, 2007

Study Completion

December 1, 2007

Last Updated

February 25, 2008

Record last verified: 2007-07

Locations

ES(1)