Half-molar sodium lactate infusion to prevent intracranial hypertensive episodes in severe traumatic brain injured patients: a randomized controlled trial
Preventive treatments of traumatic intracranial hypertension are not yet established. We aimed to compare the efficiency of half-molar sodium lactate (SL) versus saline serum solutions in preventing episodes of raised intracranial pressure (ICP) in patients with severe traumatic brain injury (TBI).
This was a double-blind, randomized controlled trial including 60 patients with severe TBI requiring ICP monitoring. Patients were randomly allocated to receive a 48-h continuous infusion at 0.5 ml/kg/h of either SL (SL group) or isotonic saline solution (control group) within the first 12 h post-trauma. Serial measurements of ICP, as well as fluid, sodium, and chloride balance were performed over the 48-h study period. The primary outcome was the number of raised ICP (≥20 mmHg) requiring a specific treatment.
Raised ICP episodes were reduced in the SL group as compared to the control group within the 48-h study period: 23 versus 53 episodes, respectively (p < 0.05). The proportion of patients presenting raised ICP episodes was smaller in the SL group than in the saline group: 11 (36 %) versus 20 patients (66 %) (p < 0.05). Cumulative 48-h fluid and chloride balances were reduced in the SL group compared to the control group (both p < 0.01).
A 48-h infusion of SL decreased the occurrence of raised ICP episodes in patients with severe TBI, while reducing fluid and chloride balances. These findings suggest that SL solution could be considered as an alternative treatment to prevent raised ICP following severe TBI.
KeywordsIntracranial pressure Intracranial hypertension Lactate solution Osmotherapy Traumatic brain injury
This paper is dedicated to the memory of Professor Xavier Leverve, who provided the intellectual framework for this clinical study. Regrettably, he died on November 8th, 2010. The research team behind this work is honored to have worked under his superb guidance and vitality.
We thank Innogene Kalbiotech, Pte. Ltd (24 Raffles Place 27 - 06 Clifford Centre, Singapore 048621, Malaysia) for their gift of NaCl and half-molar sodium lactate solutions. The half-molar sodium lactate-containing solution is patented (WO 2004/096204 -11/11/04, Gazette 2004/46) and registered (Totilac™).
The trial was investigator driven. Half-molar sodium lactate solution was kindly provided by Innogene Kalbiotech, Singapore, Malaysia. The company had no role in the study design, data collection, data analysis, data interpretation or writing of the report.
Conflicts of interest
All authors had full access to all the study data, and all agreed to submit for publication. Professor Xavier Leverve was a member of the Innogene International Scientific Board of Advisors. The other authors declare no conflict of interests.
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