Preventive Sodium Lactate and Traumatic Brain Injury

Head Trauma Clinical Trial

Official title:

Effect of Preventive Sodium Lactate Infusion on Intracranial Hypertension in Severe Trauma Tic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995683
• Other study ID #: PA-Lac-TBI
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 10, 2009
• Last updated: July 9, 2011
• Start date: June 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Institut d'Anesthesiologie des Alpes Maritimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical 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. The investigators hypothesize that preventive intravenous administration of sodium lactate will decrease the number of treatments required to decrease intracranial pressure during 48 hours.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• severe head trauma with a glasgow coma scale less than 9

Exclusion Criteria:

• prehospital cardiac arrest

• severe hemorrhage shock

• severe circulatory or respiratory failure

• medullar trauma

• prehospital osmotherapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brain Injuries
• Head Trauma
• Intracranial Hypertension

Intervention

Drug:
• half molar sodium lactate
intravenous infusion of 0.5 ml/kg during 48 hours
• isotonic sodium chloride
intravenous infusion of 0.5 ml/kg during 48 hours

Locations

Country	Name	City	State
France	Institut d'Anesthesiologie des Alpes maritimes	Nice

Sponsors (3)

Lead Sponsor	Collaborator
Institut d'Anesthesiologie des Alpes Maritimes	Medical University of Grenoble, Université de Nice Sophia Antipolis

Country where clinical trial is conducted

France, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of treatments required for intracranial hypertensive episodes during the first 48 hours following ICU admission		48 hours	No
Secondary	the neurological outcome at six months evaluated by the glasgow outcome scale		6 months	No