drugset / Trial / NCT00847977

Interest of Using Balanced Fluid for Infusion at the Early Phase of an Acute Cranial Trauma for Limiting Hyperchloremic Acidosis

NCT00847977 ↗

Phase 3 Terminated 42 enrolled Nantes University Hospital
RandomizedParallel-groupDouble-blindPrevention

Summary

isotonic NaCl serum is the first intent solution for infusion during the initial phase of reanimation for an acute cranial traumatism. However, its use can trigger an hyperchloremic metabolic acidosis, what could be deleterious for the future of this patient. Isofundine present all charateristics to be use in this indication: pharmacokinetic and pharmacodynamic similar to the physiologic serum, iso-osmolarity to plasma, no glucose provision and no interaction with hemostasis.

Timeline

Start
2008-10
Primary completion
2010-10
Completion
2010-10

Outcome

Met primary endpoint

paper hyperchloraemic acidosis within the first 48 hours (hazard ratio = 0.28, 95% confidence interval [CI] = 0.11 to 0.70; P = 0.006). PMID 23601796 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator HEAfusine Unknown — —
Subject ISOFUNDINE Unknown — —
Comparator Physiological serum Unknown — —
Subject Tetraspan Other / unclassified — —