Completed

PVI-Guided Acute Normovolemic Hemodilution for Precise Volume Management in Cardiac Surgery

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Study Aim

This study aims to manage fluid volume precisely during cardiac surgery by using PVI-guided acute normovolemic hemodilution, focusing on the amount of crystalloid used during the procedures.

What is being tested

acute normovolemic hemodilution

+ PVI dependant acute normovolemic hemodilution

Other
Who is being recruted

Pathologic Processes

+ Postoperative Complications

+ Pathological Conditions, Signs and Symptoms

From 18 to 85 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorBursa City Hospital
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on a blood conservation strategy called Acute Normovolemic Hemodilution (ANH). ANH is used during surgeries to reduce blood loss and the need for donor blood transfusions. It involves taking a certain amount of blood from the patient before surgery and replacing it with fluids, so the blood lost during surgery has less red blood cells. After surgery, the patient's own blood is returned to them. The study aims to improve this process for heart surgery patients by using a measure called the Pleth Variability Index (PVI). PVI helps doctors understand how well a patient's blood vessels are filled with fluid. The goal is to make ANH safer and more effective, potentially reducing the need for donor blood and complications related to surgery. During the study, participants undergoing heart surgery will have their ANH process guided by PVI. This means doctors will use PVI to decide how much fluid to give the patient. The main goal is to manage the patient's fluid levels more precisely. The study will measure this by looking at the amount of a specific type of fluid, called crystalloid, used during the surgery. The study also aims to find out if using PVI can reduce the need for donor blood transfusions and lower the risk of complications after surgery.

Official TitleImpact of Pleth Variability Index-Guided Acute Normovolemic Hemodilution on Intraoperative Fluid Management and Postoperative Complications in Cardiac Surgery
Principal SponsorBursa City Hospital
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic ProcessesPostoperative ComplicationsPathological Conditions, Signs and Symptoms

Criteria

5 inclusion criteria required to participate
NYHA (New York Heart Association) class I-III

hematocrit value > 35%

ASA (American Society of Anesthesiologists) score II-III

ejection fraction (LVEF) > 45%

Show More Criteria

10 exclusion criteria prevent from participating
LVEF (left ventricular ejection fraction) < 35%

severe LMCA (left main coronary artery) stenosis ( > 70%)

BMI < 18.5

Emergency or redo surgery requirement

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
In patients undergoing the ANH protocol

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Bursa City Hospital

Bursa, Turkey (Türkiye)Open Bursa City Hospital in Google Maps
CompletedOne Study Center