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临床试验/NCT02832596
NCT02832596已完成不适用

Changes in Measured Plasma Volume, Glycocalyx and Atrial Natriuretic Peptide During Anaesthesia, a Randomised Clinical Trial

Sahlgrenska University Hospital, Sweden1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
The change of plasma volume measured by 125I-HSA before anesthesia induction until 50 minutes after anesthesia induction.

研究概览

简要总结

The arterial blood pressure is thought to affect the ratio between filtration and reabsorption of fluids in the circulating blood volume and thereby the plasma volume. During induction of anesthesia blood pressure, hemoglobin level and hematocrits decreases and the plasma volume increases. The aim of the study is to evaluate weather a maintained blood pressure with norepinephrine during anesthesia induction reduces the increase in 125 iodine-labeled human serum albumine (125I-HSA) measured plasma volume.

详细描述

24 patients scheduled for coronary artery bypass surgery will be included and randomized to receive either norepinephrine in the dose needed to maintain pre-anesthesia blood pressure or to a control group and receive norepinephrine only if mean arterial pressure decreases below 60 mmHg. Equal anesthesia in both groups will be monitored. No fluids will be infused.

Changes in vascular resistance and cardiac output will be measured with thermodilution and changes in plasma volume will be measured with 125I-HSA.

Endothelial cell function will be evaluated by measuring leakage of 125I-HSA and the plasma concentration of endothelial cell markers. Hormonal effects will be evaluated by measuring the plasma concentration of atrial natriuretic peptide (ANP). Shedding of glycocalyx will be evaluated by measuring heparan sulphate. The level of fibrinogen and platelet function will be evaluated by thromboelastography/multiplate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective coronary artery surgery patients

排除标准

  • Age under 40 years
  • Untreated hypertension
  • A reduced left ventricular systolic ejection fraction of 45% or less
  • Diabetes mellitus
  • Former stroke and/or a known carotid artery stenosis

研究组 & 干预措施

Maintained blood pressure

Active Comparator

Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion

干预措施: Norepinephrine (Drug)

Maintained blood pressure

Active Comparator

Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion

干预措施: Maintained blood pressure (Procedure)

结局指标

主要结局

The change of plasma volume measured by 125I-HSA before anesthesia induction until 50 minutes after anesthesia induction.

时间窗: 50 minutes from anesthesia induction

To assess if the increase in plasma volume measured by 125I-HSA can be reduced by maintaining the blood pressure with vasopressor infusion.

次要结局

  • Difference in 125I-HSA leakage(50 minutes from anesthesia induction)
  • ANP, heparan sulphate, thrombomodulin, fibrinogen, ROTEM(50 minutes from anesthesia induction)

研究者

发起方
Sahlgrenska University Hospital, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tor Damén

Doctor

Sahlgrenska University Hospital, Sweden

研究点 (1)

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