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临床试验/NCT04042883
NCT04042883Unknown不适用

Acute Normovolemic Hemodilution Using Hydroxyethyl Starch (HES 130/0.4) in Patients Undergoing Off-pump Coronary Artery Bypass Grafting Surgery: Effects on Central and Peripheral Perfusion

Assiut University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年8月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Central venous oxygen saturation

研究概览

简要总结

To study the effects of Acute normovolemic hemodilution on central and peripheral perfusion in patients Undergoing off-pump coronary artery bypass grafting surgery

详细描述

Off-pump coronary artery bypass surgery is an alternative to conventional coronary artery bypass grafting using cardiopulmonary bypass (CPB). It avoids adverse effects of CPB such as systemic inflammatory response, impaired myocardial protection, and air or plaque embolism. However, OPCAB surgery involves displacement and manipulation of the heart to expose target coronary arteries. These manipulations cause hemodynamic instability as a result of transient annulo-mitral distortion and acute mitral regurgitation, compression of the right ventricle, and impaired cardiac contractility due to epicardial stabilizers. signs of impaired perfusion such as metabolic acidosis, increased serum lactate and decreased urine output are commonly seen intraoperatively

Excessive surgical bleeding causes hypovolemia and hemodynamic instability, anemia, and reduced oxygen delivery to tissues

Acute normovolemic hemodilution (ANH) is an alternative method of management of intraoperative blood loss, in which a certain volume of blood is collected from the patient, stored at room temperature and replaced by an equal volume of colloid solution. By the end of surgery, this blood is returned to the patient, usually within eight hours of collection, with little deterioration of platelets or coagulation factors

This work aims to study the effects of Acute normovolemic hemodilution on central and peripheral perfusion in patients Undergoing off-pump coronary artery bypass grafting surgery

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for off- pump CABG surgery

排除标准

  • Ejection fraction less than 40%
  • Hematocrit less than 11 g/dl
  • patients with severe renal impairment

研究组 & 干预措施

Control

No Intervention

No intervention

ANH

Active Comparator

500 ml of blood will be taken from the patient with simultaneous replacement with hydroxyethyl starch (HES 130/0.4) in another IV line

干预措施: Acute normovolemic hemodilution (Procedure)

结局指标

主要结局

Central venous oxygen saturation

时间窗: Intraoperative

Central venous blood gas analysis

The perfusion index

时间窗: Intraoperative

perfusion index derived from pulseoximetry

Serum lactate

时间窗: Intraoperative

from arterial blood gas analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hany Mostafa Esmaeil Osman

Principal Investigator

Assiut University

研究点 (2)

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