新型平衡明胶对围手术期电解质和 pH 值的影响。
Impact of a new balanced gelatine on electrolytes and pH in the perioperative care.
机构信息
Department of Intensive Care Medicine and Intermediate Care, University Hospital RWTH Aachen, Medical Faculty RWTH Aachen University, Aachen, Germany.
Department of Anesthesiology, Intensive Care Medfiicine & Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany.
出版信息
PLoS One. 2019 Apr 29;14(4):e0213057. doi: 10.1371/journal.pone.0213057. eCollection 2019.
INTRODUCTION
Balanced fluid replacement solutions can possibly reduce the risks for electrolyte imbalances, for acid-base imbalances, and thus for renal failure. To assess the intraoperative change of base excess (BE) and chloride in serum after treatment with either a balanced gelatine/electrolyte solution or a non-balanced gelatine/electrolyte solution, a prospective, controlled, randomized, double-blind, dual centre phase III study was conducted in two tertiary care university hospitals in Germany.
MATERIAL AND METHODS
40 patients of both sexes, aged 18 to 90 years, who were scheduled to undergo elective abdominal surgery with assumed intraoperative volume requirement of at least 15 mL/kg body weight gelatine solution were included. Administration of study drug was performed intravenously according to patients need. The trigger for volume replacement was a central venous pressure (CVP) minus positive end-expiratory pressure (PEEP) <10 mmHg (CVP <10 mmHg). The crystalloid:colloid ratio was 1:1 intra- and postoperatively. The targets for volume replacement were a CVP between 10 and 14 mmHg minus PEEP after treatment with vasoactive agent and mean arterial pressure (MAP) > 65 mmHg.
RESULTS
The primary endpoints, intraoperative changes of base excess -2.59 ± 2.25 (median: -2.65) mmol/L (balanced group) and -4.79 ± 2.38 (median: -4.70) mmol/L (non-balanced group)) or serum chloride 2.4 ± 1.9 (median: 3.0) mmol/L and 5.2 ± 3.1 (median: 5.0) mmol/L were significantly different (p = 0.0117 and p = 0.0045, respectively). In both groups (each n = 20) the investigational product administration in terms of volume and infusion rate was comparable throughout the course of the study, i.e. before, during and after surgery.
DISCUSSION
Balanced gelatine solution 4% combined with a balanced electrolyte solution demonstrated significant smaller impact on blood gas analytic parameters in the primary endpoints BE and serum chloride when compared to a non-balanced gelatine solution 4% combined with NaCl 0.9%. No marked treatment differences were observed with respect to haemodynamics, coagulation and renal function.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT01515397) and clinicaltrialsregister.eu, EudraCT number 2010-018524-58.
简介
平衡液替代疗法可能降低电解质失衡、酸碱失衡和肾衰竭的风险。为评估术中使用平衡胶体电解质溶液和非平衡胶体电解质溶液治疗后基础代谢过剩（BE）和血清氯的变化，在德国两家三级教学医院进行了一项前瞻性、对照、随机、双盲、双中心 III 期研究。
材料和方法
选择 40 名年龄 18-90 岁的择期行腹部手术患者，预计术中胶体需求量至少 15ml/kg 体重明胶溶液。根据患者需要静脉输注研究药物。容量替代的触发因素是中心静脉压（CVP）减去呼气末正压（PEEP）<10mmHg（CVP<10mmHg）。术中及术后晶体：胶体比为 1：1。容量替代的目标是血管活性药物治疗后 CVP 在 10-14mmHg 之间，PEEP 减去平均动脉压（MAP）>65mmHg。
结果
主要终点是术中基础代谢过剩的变化-2.59±2.25（中位数：-2.65）mmol/L（平衡组）和-4.79±2.38（中位数：-4.70）mmol/L（非平衡组））或血清氯 2.4±1.9（中位数：3.0）mmol/L 和 5.2±3.1（中位数：5.0）mmol/L 差异显著（p=0.0117 和 p=0.0045）。在两组（每组 n=20）中，研究产品的给药量和输注速度在整个研究过程中相似，即在手术前、手术中和手术后。
讨论
4%的平衡明胶溶液与平衡电解质溶液联合应用与 4%的非平衡明胶溶液与氯化钠 0.9%联合应用相比，在基础代谢过剩和血清氯的主要终点方面对血气分析参数的影响明显较小。在血流动力学、凝血和肾功能方面没有明显的治疗差异。
试验注册
ClinicalTrials.gov（NCT01515397）和 clinicaltrialsregister.eu，EudraCT 编号 2010-018524-58。
Zotero 插件