Head TraumaPhase 2/3NCT00995683
Preventive Sodium Lactate and Traumatic Brain Injury
A Phase 2/3 study testing half molar sodium lactate and isotonic sodium chloride in people with Head Trauma, run by Institut d'Anesthesiologie des Alpes Maritimes at 1 site in France.
Trial summary
The goal of this study is to evaluate the effect of preventive intravenous infusion of half molar sodium lactate on the onset of hypertensive intracranial episodes in severe head trauma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head Trauma
- What is being tested?
- half molar sodium lactate and isotonic sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to May 2011
- Phase
- Phase 2/3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe head trauma with a glasgow coma scale less than 9
Who cannot join
- prehospital cardiac arrest
- severe hemorrhage shock
- severe circulatory or respiratory failure
- medullar trauma
- prehospital osmotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preventive Sodium Lactate Infusion on Intracranial Hypertension in Severe Trauma Tic Brain Injury
The goal of this study is to evaluate the effect of preventive intravenous infusion of half molar sodium lactate on the onset of hypertensive intracranial episodes in severe head trauma. The investigators hypothesize that preventive intravenous administration of sodium lactate will decrease the number of treatments required to decrease intracranial pressure during 48 hours.
Read the detailed description
- Intracranial hypertension is the most severe complication of severe head injury. This may lead to cerebral death or severe neurological outcome. To improve the prognosis of these patients,intracranial pressure must be maintained in normal range while maintaining cerebral perfusion pressure. Among numerous strategies, osmotherapy is frequently proposed to decrease intracranial pressure, using mannitol or hypertonic saline. Recently, it has been found that hypertonic sodium lactate infusion is more efficient to decrease intracranial hypertension compared with an equivalent volemic and osmotic mannitol administration.Thus, we hypothesized that a preventive sodium lactate infusion in severe head trauma could decrease the number of intracranial hypertensive episodes.
- Methods and Objectives : to compare in a randomized double-blind fashion two group of patients, i.e., those receiving a standard isotonic saline infusion (control group) with those receiving half-molar sodium lactate for 48 hours following admission in ICU. The primary endpoint is the number of any treatment required to control intracranial hypertensive episodes occurring during the first 48 hours following admission in ICU. Secondary endpoints are the effect of sodium lactate infusion on : intracranial pressure evolution;neurological outcome at 6 months (glasgow outcome scale); cerebral blood flow evaluated by transcranial doppler; and daily water balance
- Protocol consisted to measure as soon as possible baseline intracranial pressure and cerebral perfusion pressure, then immediately to begin the administration of 0.5 ml/kg/h intravenous isotonic saline perfusion or half-molar sodium lactate during 48 hours in a randomized double-blind fashion. Management of patients is the same for all patients. Treatment required for intracranial hypertensive episode is decided by a senior physician in charge of the patient. Sample size has been calculated considering that 50% of these patients will develop at least one intracranial hypertensive episode, each of them requiring at least 2 treatments. Based on previous results, we hypothesized that sodium lactate will decrease the number of required treatment by 2, leading to a sample size of 30 patients per group
- Follow up : 48 hours for treatments of intracranial hypertensive episodes; 6 months for the neurological outcome (glasgow outcome scale)
- Conditions
- Head Trauma
- Being tested
- half molar sodium lactate, isotonic sodium chloride
- Keywords
- intracranial hypertension, neurological outcome, osmotherapy
- Medical subject headings
- Craniocerebral Trauma, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
half molar sodium lactateDrug
Also called sodium lactate
intravenous infusion of 0.5 ml/kg during 48 hours
isotonic sodium chlorideDrug
Also called sodium chloride
intravenous infusion of 0.5 ml/kg during 48 hours
| Study group | Role | What they receive |
|---|---|---|
| half sodium lactate | Experimental | infusion of 0.5 ml/kg/day during 48 hours Receives: Drug: half molar sodium lactate |
| isotonic sodium chloride | Active comparator | infusion of 0.5 ml/kg during 48 hours Receives: Drug: isotonic sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of treatments required for intracranial hypertensive episodes during the first 48 hours following ICU admission
Measured: 48 hours
Secondary outcomes (1)
the neurological outcome at six months evaluated by the glasgow outcome scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head TraumaStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Anesthesiologie des Alpes Maritimes
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Nice Sophia Antipolis, Medical University of Grenoble
- Investigators
- Carole Ichai, MD, PhD, Principal investigator, Institut d'Anesthesiologie des Alpes Maritimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995683
- Sponsor's protocol ID
- PA-Lac-TBI
- Status last verified
- May 2011
- First submitted
- 10 Oct 2009
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ichai C, Armando G, Orban JC, Berthier F, Rami L, Samat-Long C, Grimaud D, Leverve X. Sodium lactate versus mannitol in the treatment of intracranial hypertensive episodes in severe traumatic brain-injured patients. Intensive Care Med. 2009 Mar;35(3):471-9. doi: 10.1007/s00134-008-1283-5. Epub 2008 Sep 20.
PubMed 18807008
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preventive Sodium Lactate Infusion on Intracranial Hypertension in Severe Trauma Tic Brain Injury
- ClinicalTrials.gov ID
- NCT00995683
- Acronym / sponsor ID
- PA-Lac-TBI
- Conditions
- Head Trauma
- Keywords
- intracranial hypertension, neurological outcome, osmotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut d'Anesthesiologie des Alpes MaritimesUniversity, hospital or other
- Collaborators
- Université de Nice Sophia Antipolis, Medical University of Grenoble
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Oct 2009 (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.
The goal of this study is to evaluate the effect of preventive intravenous infusion of half molar sodium lactate on the onset of hypertensive intracranial episodes in severe head trauma. The investigators hypothesize that preventive intravenous administration of sodium lactate will decrease the number of treatments required to decrease intracranial pressure during 48 hours.
Detailed description
- Intracranial hypertension is the most severe complication of severe head injury. This may lead to cerebral death or severe neurological outcome. To improve the prognosis of these patients,intracranial pressure must be maintained in normal range while maintaining cerebral perfusion pressure. Among numerous strategies, osmotherapy is frequently proposed to decrease intracranial pressure, using mannitol or hypertonic saline. Recently, it has been found that hypertonic sodium lactate infusion is more efficient to decrease intracranial hypertension compared with an equivalent volemic and osmotic mannitol administration.Thus, we hypothesized that a preventive sodium lactate infusion in severe head trauma could decrease the number of intracranial hypertensive episodes.
- Methods and Objectives : to compare in a randomized double-blind fashion two group of patients, i.e., those receiving a standard isotonic saline infusion (control group) with those receiving half-molar sodium lactate for 48 hours following admission in ICU. The primary endpoint is the number of any treatment required to control intracranial hypertensive episodes occurring during the first 48 hours following admission in ICU. Secondary endpoints are the effect of sodium lactate infusion on : intracranial pressure evolution;neurological outcome at 6 months (glasgow outcome scale); cerebral blood flow evaluated by transcranial doppler; and daily water balance
- Protocol consisted to measure as soon as possible baseline intracranial pressure and cerebral perfusion pressure, then immediately to begin the administration of 0.5 ml/kg/h intravenous isotonic saline perfusion or half-molar sodium lactate during 48 hours in a randomized double-blind fashion. Management of patients is the same for all patients. Treatment required for intracranial hypertensive episode is decided by a senior physician in charge of the patient. Sample size has been calculated considering that 50% of these patients will develop at least one intracranial hypertensive episode, each of them requiring at least 2 treatments. Based on previous results, we hypothesized that sodium lactate will decrease the number of required treatment by 2, leading to a sample size of 30 patients per group
- Follow up : 48 hours for treatments of intracranial hypertensive episodes; 6 months for the neurological outcome (glasgow outcome scale)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| half sodium lactate | Experimental | Drug: half molar sodium lactateinfusion of 0.5 ml/kg/day during 48 hours |
| isotonic sodium chloride | Active comparator | Drug: isotonic sodium chlorideinfusion of 0.5 ml/kg during 48 hours |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe head trauma with a glasgow coma scale less than 9
Key exclusion criteria (5 listed)
- prehospital cardiac arrest
- severe hemorrhage shock
- severe circulatory or respiratory failure
- medullar trauma
- prehospital osmotherapy
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 |
|---|---|---|
| half molar sodium lactateAlso: sodium lactateintravenous infusion of 0.5 ml/kg during 48 hours | Drug | half sodium lactate |
| isotonic sodium chlorideAlso: sodium chlorideintravenous infusion of 0.5 ml/kg during 48 hours | Drug | isotonic sodium chloride |
Primary outcome
the number of treatments required for intracranial hypertensive episodes during the first 48 hours following ICU admission
Time frame: 48 hours
1 secondary outcome
the neurological outcome at six months evaluated by the glasgow outcome scale
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
- Results publication: PubMed 18807008Ichai C, Armando G, Orban JC, Berthier F, Rami L, Samat-Long C, Grimaud D, Leverve X. Sodium lactate versus mannitol in the treatment of intracranial hypertensive episodes in severe traumatic brain-injured patients. Intensive Care Med. 2009 Mar;35(3):471-9. doi: 10.1007/s00134-008-1283-5. Epub 2008 Sep 20.
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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.
Carole Ichai, MD, PhD principal investigator
Institut d'Anesthesiologie des Alpes Maritimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing half molar sodium lactate and isotonic sodium chloride in people with Head Trauma, run by Institut d'Anesthesiologie des Alpes Maritimes at 1 site in France.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jul 2011. 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 France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the number of treatments required for intracranial hypertensive episodes during the first 48 hours following ICU admission (time frame: 48 hours). 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 NCT00995683, which also lists 1 linked publication.
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 12 Jul 2011.