Preventive Sodium Lactate and Traumatic Brain Injury

Phase 2/3 Completed 60 enrolled Institut d'Anesthesiologie des Alpes Maritimes Medical University of Grenoble · collab Université de Nice Sophia Antipolis · collab

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2009-06
Primary completion: 2011-05
Completion: 2011-05

Outcome

Met primary endpoint

paper Compared to mannitol, the effect of the lactate solution on ICP was significantly more pronounced (7 vs. 4 mmHg, P = 0.016) PMID 18807008 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sodium Lactate	Other / unclassified	0.5 unknown	Intravenous
Comparator	sodium chloride	Unknown	0.5 unknown	Intravenous