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临床试验/NCT07466082
NCT07466082已完成不适用

Impact of Pleth Variability Index-Guided Acute Normovolemic Hemodilution on Intraoperative Fluid Management and Postoperative Complications in Cardiac Surgery

Bursa City Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年11月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Fluid management

研究概览

简要总结

Acute normovolemic hemodilution (ANH) is a widely used blood conservation strategy in cardiac surgery aimed at reducing intraoperative blood loss and the need for allogeneic blood transfusion. However, inadequate or excessive fluid replacement during ANH may lead to hemodynamic instability and other complications. The Pleth Variability Index (PVI) is a noninvasive dynamic parameter that can predict fluid responsiveness and guide goal-directed fluid therapy during surgery. This study aims to evaluate whether performing ANH under intraoperative PVI guidance in cardiac surgery allows more precise fluid management and reduces allogenic blood transfusion and the risk of perioperative complications.

详细描述

Acute normovolemic hemodilution (ANH) is a blood conservation strategy used to reduce intraoperative blood loss and minimize the need for allogeneic blood transfusion. The technique involves withdrawing a predetermined volume of whole blood from the patient before surgery and replacing it with crystalloid or colloid solutions to maintain intravascular volume. Consequently, blood lost during surgery contains a lower hemoglobin concentration due to hemodilution, and the patient's hemoglobin level is subsequently restored through reinfusion of the collected autologous blood after the surgical procedure [1]. Based on available evidence, the European Society of Anaesthesiology recommends the use of ANH in perioperative bleeding management guidelines to reduce the need for allogeneic blood transfusion [2].

Although ANH is generally considered a safe technique, inadequate or excessive intravenous fluid replacement may lead to several potential adverse effects, including hemodynamic instability, anemia, increased myocardial oxygen consumption due to high cardiac output, dilutional coagulopathy, electrolyte imbalance, and renal dysfunction [3].

The Pleth Variability Index (PVI) is a noninvasive monitoring parameter derived from pulse oximetry that evaluates fluid responsiveness by analyzing respiratory variations in the plethysmographic waveform amplitude [4]. Particularly in patients receiving positive pressure ventilation, PVI can serve as a useful indicator for assessing intravascular volume status. As a dynamic and continuously monitored parameter, PVI has been shown to predict fluid responsiveness and facilitate goal-directed fluid therapy. Studies have demonstrated that PVI-guided fluid management may reduce the total volume of administered fluids compared with conventional fluid administration strategies [5].

Currently, no standardized protocol exists for the implementation of ANH, and its application often depends on institutional or local procedural guidelines [6]. Traditionally, ANH is performed using a 1:3 fluid replacement ratio during acute blood withdrawal, and the amount of blood to be collected is calculated using the formula:

ANH volume = (patient Hb - target Hb) / mean Hb × blood volume,

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
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA (American Society of Anesthesiologists) score II-III,
  • ejection fraction (LVEF) >45%,
  • NYHA (New York Heart Association) class I-III,
  • hematocrit value >35%,
  • and patients who have not had a myocardial infarction in the last three months.

排除标准

  • Emergency or redo surgery requirement,
  • LVEF (left ventricular ejection fraction) <35%,
  • severe LMCA (left main coronary artery) stenosis (>70%),
  • BMI <18.5,
  • severe comorbidity (endocarditis, advanced COPD (chronic obstructive pulmonary disease), CKD (chronic kidney disease), anemia, hypoalbuminemia, peripheral artery disease),
  • active DAPT /heparin use,
  • coagulopathy,
  • uncontrolled systemic diseases,
  • pregnancy,
  • malignancy

研究组 & 干预措施

Group 1 (Conventional Group)

Active Comparator

In patients undergoing the ANH protocol

干预措施: acute normovolemic hemodilution (Other)

Group 2 (PVI Group)

Experimental

In patients undergoing PVI-guided ANH (Masimo SET® and rainbow® Pulse CO-Oximetry)

干预措施: PVI dependant acute normovolemic hemodilution (Other)

结局指标

主要结局

Fluid management

时间窗: -during ANH -Total cristalloid amount during surgery -total cristalloid amount during CPB -postoperative cristalloid amount in first 24.hour

amount of crystalloid used during procedures

次要结局

  • Allogenic Blood Transfusion(-intraoperative -postoperative 24.hour)
  • Postoperative Complications(postoperative 24 hours)

研究者

发起方
Bursa City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

eralp çevikkalp

associate professor

Bursa City Hospital

研究点 (1)

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