Roquilly Antoine, Loutrel Olivier, Cinotti Raphael, Rosenczweig Elise, Flet Laurent, Mahe Pierre Joachim, Dumont Romain, Marie Chupin Anne, Peneau Catherine, Lejus Corinne, Blanloeil Yvonnick, Volteau Christelle, Asehnoune Karim
Crit Care. 2013 Apr 19;17(2):R77. doi: 10.1186/cc12686.
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.
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.
Forty-two patients were included, of whom one patient in each group was excluded (one consent withdrawn and one use of forbidden therapy).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).
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.
EudraCT 2008-004153-15 and NCT00847977.
我们旨在研究使用平衡液是否能降低重度脑损伤患者高氯性酸中毒的发生率，同时不增加颅内高压的风险。
我们在法国南特进行了一项单中心、双臂、随机、双盲、试点对照试验。对因严重创伤性脑损伤（格拉斯哥昏迷量表评分≤8）或蛛网膜下腔出血（世界神经外科协会联合会分级为III级或更高）而接受机械通气的患者，在脑损伤后的前12小时内随机分组，分别接受等渗平衡液（晶体液和羟乙基淀粉；平衡液组）或等渗氯化钠溶液（晶体液和羟乙基淀粉；生理盐水组）治疗48小时。主要终点是48小时内发生高氯性代谢性酸中毒。
共纳入42例患者，每组各有1例患者被排除（1例撤回同意书，1例使用了禁用治疗方法）。生理盐水组19例患者（95%）和平衡液组13例患者（65%）在最初48小时内出现高氯性酸中毒（风险比=0.28，95%置信区间[CI]=0.11至0.70；P=0.006）。与平衡液组相比，生理盐水组的pH值（P=0.004）和强离子间隙（P=0.047）较低，血氯水平较高（P=0.002）。研究组之间的颅内压无差异（平均差异4 mmHg[-1;8]；P=0.088）。生理盐水组7例患者（35%）和平衡液组8例患者（40%）发生颅内高压（P=0.744）。生理盐水组3例患者（14%）和平衡液组5例患者（25%）死亡（P=0.387）。
本研究提供了证据表明，与生理盐水相比，平衡液可降低脑损伤患者高氯性酸中毒的发生率。即使该研究针对此终点的效能不足，但两组之间的颅内压似乎并无差异。
EudraCT 2008-004153-15和NCT00847977。
