Cosmin Balan, Cristian Boros, Serban-Ion Bubenek-Turconi, Robert G Hahn
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引用次数: 0
Abstract
Objectives: The volume kinetics of a commercially available colloid fluid, Gelofusine, have not been studied previously.
Methods: Intravenous Gelofusine 10 mL/kg was infused over 30 min in 15 patients undergoing vascular surgery. Of the 15 patients, 14 were classified as American Society of Anesthesiologists (ASA) class III status. The distribution and elimination of the infused volume was calculated with mixed-model kinetics based on 280 measurements of the hemoglobin-derived plasma dilution (19 per patient) collected over 180 min.
Results: The expanded central fluid space volume (Vc, the plasma) amounted to 2.16 L (95% confidence interval [CI] 1.06-2.35) at baseline. The maximum volume expansion of Vc was 706 mL (95% CI 599-812) after infusing Gelofusine 800 mL. Elimination occurred with a half-life of 115 min (95% CI 110-124). Noradrenaline was infused in eight of the 15 patients, leading to a dose-dependent reduction in elimination half-life. For example, an infusion rate of 3 µg/min decreased the half-life to 60 min (- 48%). Distribution of the infused volume to the extravascular space was small (15%), and redistribution to the plasma was accelerated by noradrenaline. Mean arterial pressure and urinary creatinine were not statistically significant covariates, and the model was not strengthened by considering the urine output. Infusion protocols aiming to achieve steady state plasma volume expansion during surgery can begin with a fast infusion over 20 min, then decreasing the rate by 80%.
Conclusion: The kinetics of Gelofusine was predictable in patients of American Society of Anesthesiologists class III status undergoing vascular surgery, with the fluid expanding the vascular space and the half-life shortened by noradrenaline.
Trial registration: Retrospectively registered with ClinicalTrials.gov NCT06474052, June 24, 2024.
目的：市售胶体流体Gelofusine的体积动力学尚未被研究过。方法：对15例血管手术患者静脉滴注格洛夫辛10 mL/kg，持续30 min。15例患者中，14例被美国麻醉医师协会（ASA）分类为III级。根据180分钟内收集的280次血红蛋白衍生血浆稀释（每位患者19次）测量结果，使用混合模型动力学计算输注体积的分布和消除。结果：基线时扩大的中央液体空间体积（Vc，血浆）为2.16 L（95%置信区间[CI] 1.06-2.35）。注射Gelofusine 800 mL后，Vc的最大体积膨胀为706 mL (95% CI 599-812)，半衰期为115 min （95% CI 110-124）。15例患者中有8例输注去甲肾上腺素，导致消除半衰期的剂量依赖性减少。例如，3µg/min的输注速率将半衰期缩短至60 min（- 48%）。输注量在血管外空间的分布很小（15%），去甲肾上腺素加速了再分布到血浆。平均动脉压和尿肌酐是无统计学意义的协变量，考虑尿量后模型没有得到加强。输注方案的目的是在手术过程中实现稳态血浆容量扩张，可以从快速输注20分钟开始，然后将输注速率降低80%。结论：Gelofusine在接受血管手术的美国麻醉医师学会III级患者中的动力学是可预测的，去甲肾上腺素使血管间隙扩大，半衰期缩短。试验注册：回顾性注册于ClinicalTrials.gov NCT06474052, 2024年6月24日。
期刊介绍：
Clinical Pharmacokinetics promotes the continuing development of clinical pharmacokinetics and pharmacodynamics for the improvement of drug therapy, and for furthering postgraduate education in clinical pharmacology and therapeutics.
Pharmacokinetics, the study of drug disposition in the body, is an integral part of drug development and rational use. Knowledge and application of pharmacokinetic principles leads to accelerated drug development, cost effective drug use and a reduced frequency of adverse effects and drug interactions.
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