Traumatic Brain InjuryPhase 3NCT00622570
Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension
A Phase 3 study testing Pentobarbital and thiopental in people with Traumatic Brain Injury, run by Hospital Universitari Son Dureta at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Pentobarbital and thiopental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- May 2002to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previously known ischemic heart failure (Ejection fraction < 35%)
- Pregnancy
- bilateral dilated and unreactive pupils and a GCS of 3
- Intolerance to barbiturates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension.
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Pentobarbital, thiopental
- Keywords
- Traumatic brain injury, barbiturate coma
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentobarbitalDrug
Also called Nembutal(r)
10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h
thiopentalDrug
Also called PENTOTHAL(R)
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pentobarbital Receives: Drug: Pentobarbital |
| 2 | Active comparator | thiopental Receives: Drug: thiopental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial pressure control
Measured: along intensive care unit stay
Secondary outcomes (2)
Hypotension (Mean arterial blood pressure<80 mmHg)
Measured: during barbiturate treatment
Infection
Measured: during barbiturate treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startMay 2002
- Primary completionJul 2007
- Study completionDec 2007
Why it stopped: Slowly recruitment rate. Intermediate analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Son Dureta
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Investigators
- Jon Perez, MD, Principal investigator, Son Dureta Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622570
- Sponsor's protocol ID
- PI 02/0642
- Other IDs
- IB
- Status last verified
- Jul 2007
- First submitted
- 14 Feb 2008
- Last updated
- 25 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15756405Perez-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.
PubMed 18759980
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension.
- ClinicalTrials.gov ID
- NCT00622570
- Acronym / sponsor ID
- PI 02/0642
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury, barbiturate coma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slowly recruitment rate. Intermediate analysis
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hospital Universitari Son DuretaUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Study start
- May 2002
- Primary completion
- Jul 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PentobarbitalPentobarbital |
| 2 | Active comparator | Drug: thiopentalthiopental |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Previously known ischemic heart failure (Ejection fraction < 35%)
- Pregnancy
- bilateral dilated and unreactive pupils and a GCS of 3
- Intolerance to barbiturates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PentobarbitalAlso: Nembutal(r)10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h | Drug | 1 |
| thiopentalAlso: PENTOTHAL(R)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 | Drug | 2 |
Primary outcome
Intracranial pressure control
Time frame: along intensive care unit stay
2 secondary outcomes
Hypotension (Mean arterial blood pressure<80 mmHg)
Time frame: during barbiturate treatment
Infection
Time frame: during barbiturate treatment
Results and safety
The study was stopped early (reason given: Slowly recruitment rate. Intermediate analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2008.
- Results publication: PubMed 15756405Perez-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.
- Derived from this study: PubMed 18759980Perez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Perez, MD principal investigator
Son Dureta Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pentobarbital and thiopental in people with Traumatic Brain Injury, run by Hospital Universitari Son Dureta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slowly recruitment rate. Intermediate analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial pressure control (time frame: along intensive care unit stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00622570, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2008.