Clinical Trials Logo
  1. Home
  2. Intracranial Hypertension
  3. NCT00319345

Sodium-Lactate and Traumatic Brain Injury

Intracranial Hypertension Clinical Trial

Official title:
Sodium-Lactate Versus Mannitol in the Treatment of Intracranial Hypertensive Episodes in Severe Traumatic Brain Injured Patients

Clinical Trial Summary

The purpose of this study is to compare the effect of bolus of either sodium-lactate or mannitol on the evolution of intracranial pressure (ICP) during intracranial hypertensive episodes (IHE)

Clinical Trial Description

Osmotherapy with mannitol remains the first treatment currently recommended to treat intracranial hypertension in severe head injury.However, this treatment in not always efficient and is associated with side-effects and a transitory action. Hypertonic sodium-lactate, by its osmotic and energetic properties could be superior to mannitol to decrease ICP. Study objectives : to compare the effect of mannitol and sodium-lactate on ICP at the fourth hour after the start of infusion during IHE in severe traumatic brain injury (TBI) (main endpoint) ; to compare the percentage of successfully treated episodes between both treatments and to compare the neurological status after one year of evolution (glasgow outcome score)(secondary endpoints)

Patients inclusion : adult severe TBI (glasgow coma score < 9) < 66 yrs Exclusion criteria : polytrauma, bilateral fixed dilated pupils, motor score < 4, neurosurgery, prolonged episode of hypoxia or arterial hypotension, 34 patients included from november 2003 to november 2004 and randomized into two groups : MAN group receiving mannitol 20% 100 ml in 15 min (17 patients, 36 episodes of IHE treated) and LAC group receiving semimolar sodium-lactate 100 ml in 15 min (17 patients, 37 episodes of IHE treated). For ethical reasons a rescue treatment in a crossover fashion was performed for each episode of IHE when the randomized treatment failed.

Follow-up : one year after the TBI. Study end : november 30, 2005 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00319345
Study type Interventional
Source Institut d'Anesthesiologie des Alpes Maritimes
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date November 2003
Completion date November 2005
View Details
See also
  Status Clinical Trial Phase
Completed NCT06367868 - Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring N/A
Completed NCT04488874 - Sodium Lactate and Brain Relaxation (LSD) Phase 3
Not yet recruiting NCT04211064 - Comparison of the Effects of Deep and Moderate Neuromuscular Blockade on Optic Nerve Sheath Diameter N/A
Completed NCT00571623 - Automated Chest Physiotherapy to Improve Outcomes in Neuro N/A
Recruiting NCT00437814 - Effect of Ketamine (Ketalar) on Intracranial Pressure N/A
Recruiting NCT03212976 - Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure N/A
Withdrawn NCT02558309 - Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure N/A
Terminated NCT00795587 - Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring Phase 4
Completed NCT00447018 - Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure Phase 4
Not yet recruiting NCT05593380 - The Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH N/A
Completed NCT03364634 - Intracranial Pressure After Decompressive Craniectomy N/A
Unknown status NCT02773901 - Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement N/A
Terminated NCT01973764 - Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System N/A
Recruiting NCT04459806 - Intracranial PrEssure Time dOse (ImPETO)
Completed NCT00239525 - 3-D Transcranial Ultrasound Analysis Study N/A
Completed NCT05946200 - Optic Nerve Sheath Diameter in Low-flow and Normal-flow Rate Anesthesia N/A
Completed NCT03957837 - Optical Nerve Sheath Changes During Head Down Laparoscopy
Not yet recruiting NCT05818371 - Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting N/A
Completed NCT04429477 - Cerebral Compliance Impairment in COVID-19
Recruiting NCT03144219 - A Novel Non-invasive Technique of Cerebral Compliance and Auto-regulation Assessment