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Balanced versus chloride-rich solutions for fluid resuscitation in brain-injured patients: a randomised double-blind pilot study

Antoine Roquilly1, Olivier Loutrel1, Raphael Cinotti2, Elise Rosenczweig3, Laurent Flet4, Pierre Joachim Mahe1, Romain Dumont1, Anne Marie Chupin1, Catherine Peneau1, Corinne Lejus1, Yvonnick Blanloeil2, Christelle Volteau5 and Karim Asehnoune1*

Author Affiliations

1 Pôle Anesthésie-Réanimations, Service d'anesthésie réanimation Hôtel-Dieu, CHU Nantes, F-44000 Nantes, France

2 Pôle Anesthésie-Réanimations, Service d'anesthésie réanimation Hôpital Laennec, CHU Nantes, F-44000 Nantes, France

3 Pôle Anesthésie-Réanimations, Service de réanimation médicale polyvalente, CHU Nantes, F-44000 Nantes, France

4 Pôle Pharmacie, Service HOTEL-DIEU-Essais cliniques, CHU Nantes, F-44000 Nantes, France

5 Cellule de Biostatistiques-Cellule de promotion à la recherche clinique, CHU Nantes, F-44000 Nantes, France

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Critical Care 2013, 17:R77  doi:10.1186/cc12686

Published: 19 April 2013

Abstract

Introduction

We sought to investigate whether the use of balanced solutions reduces the incidence of hyperchloraemic acidosis without increasing the risk for intracranial hypertension in patients with severe brain injury.

Methods

We conducted a single-centre, two-arm, randomised, double-blind, pilot controlled trial in Nantes, France. Patients with severe traumatic brain injury (Glasgow Coma Scale score ≤8) or subarachnoid haemorrhage (World Federation of Neurosurgical Society grade III or higher) who were mechanically ventilated were randomised within the first 12 hours after brain injury to receive either isotonic balanced solutions (crystalloid and hydroxyethyl starch; balanced group) or isotonic sodium chloride solutions (crystalloid and hydroxyethyl starch; saline group) for 48 hours. The primary endpoint was the occurrence of hyperchloraemic metabolic acidosis within 48 hours.

Results

Forty-two patients were included, of whom one patient in each group was excluded (one consent withdrawn and one use of forbidden therapy). Nineteen patients (95%) in the saline group and thirteen (65%) in the balanced group presented with hyperchloraemic acidosis within the first 48 hours (hazard ratio = 0.28, 95% confidence interval [CI] = 0.11 to 0.70; P = 0.006). In the saline group, pH (P = .004) and strong ion deficit (P = 0.047) were lower and chloraemia was higher (P = 0.002) than in the balanced group. Intracranial pressure was not different between the study groups (mean difference 4 mmHg [-1;8]; P = 0.088). Seven patients (35%) in the saline group and eight (40%) in the balanced group developed intracranial hypertension (P = 0.744). Three patients (14%) in the saline group and five (25%) in the balanced group died (P = 0.387).

Conclusions

This study provides evidence that balanced solutions reduce the incidence of hyperchloraemic acidosis in brain-injured patients compared to saline solutions. Even if the study was not powered sufficiently for this endpoint, intracranial pressure did not appear different between groups.

Trial registration

EudraCT 2008-004153-15 and NCT00847977

The work in this trial was performed at Nantes University Hospital in Nantes, France.