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临床试验/NCT01348659
NCT01348659已完成4 期

Effects of Hypertonic Saline-hydroxyethyl Starch Solution on Extracellular Water in Cardiac Surgery Patients

Kati Järvelä1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Change in extracellular water from baseline to the first postoperative morning.

研究概览

简要总结

The aim of the study is to describe the effects of hypertonic saline/hydroxyethylstarch solution in comparison to saline solution for 25 + 25 patients undergoing coronary bypass grafting surgery (CABG) using CPB. The study fluid will be given into the venous reservoir of the CPB circuit after aortic declamping. Primary endpoints are the changes in body weight and extracellular water from baseline to the first postoperative morning.

详细描述

Cardiac surgery and cardiopulmonary bypass (CPB) cause fluid retention in the body. Both dilution of serum proteins and destruction of vascular endothelial glycocalyx cause extravasation of the fluids. We cannot avoid this phenomenon but we can try to restore the excess fluid into the intravascular space where it can be excreted via the kidneys.

Hypertonic saline (HS) creates an osmotic gradient across the cellular membrane, causing a fluid shift from the intracellular space into the extracellular space and from the extravascular space into the intravascular space. The intravascular hypertonic benefit is short-lasting as a result of redistribution of fluid between the intravascular and interstitial spaces. The effect can be lengthened by adding colloid component into the solution.

The aim of the study is to describe the effects of hypertonic saline/hydroxyethylstarch solution in comparison to saline solution for 25 + 25 patients undergoing coronary bypass grafting surgery (CABG) using CPB. The study fluid will be given into the venous reservoir of the CPB circuit after aortic declamping. Primary endpoints are the changes in body weight and extracellular water from baseline to the first postoperative morning. Secondary endpoints are the need of fluids and diuretic medication during the perioperative period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • male gender and no need for pulmonary artery catheter (pulmonary hypertension or left ventricular ejection fraction < 40%).

排除标准

  • chronic hyponatremia and significant renal dysfunction.

研究组 & 干预措施

7.2% NaCl/hydroxyethyl starch

Active Comparator

250 ml of 7.2% NaCl in hydroxyethylstarch (HES 200/0,5) (Hyperhaes®, Fresenius Kabi)

干预措施: 7.2% NaCl/hydroxyethylstarch (Drug)

0.9% NaCl

Active Comparator

250 ml of NaCl 0.9% (Natriumklorid Braun 9 mg/ml)

干预措施: NaCl 0.9% (Drug)

结局指标

主要结局

Change in extracellular water from baseline to the first postoperative morning.

时间窗: 24h

Perioperative fluid balance will be assessed by measuring changes in body weight and extracellular water from baseline to the first postoperative morning.

次要结局

  • Need of fluids during the day of surgery.(24h)

研究者

发起方
Kati Järvelä
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kati Järvelä

MD, PhD

Tampere University Hospital

研究点 (1)

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