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

NCT07466082 | Completed

• 1 other identifier: 2025-KAEK-47
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Normovolemic Hemodilution; Cardiac Surgery; Postoperative Complication; Pleth Variability Index

Keywords

acute normovolemic hemodilution; cardiac surgery; Pleth variability index; fluid management

Outcome Measures

Primary Outcomes (1)

• Fluid management

  amount of crystalloid used during procedures

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

Secondary Outcomes (2)

• Allogenic Blood Transfusion

  -intraoperative -postoperative 24.hour

• Postoperative Complications

  postoperative 24 hours

Study Arms (2)

Group 1 (Conventional Group)

ACTIVE COMPARATOR

In patients undergoing the ANH protocol

Other: acute normovolemic hemodilution

Group 2 (PVI Group)

EXPERIMENTAL

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

Other: PVI dependant acute normovolemic hemodilution

Interventions

acute normovolemic hemodilution OTHER

ANH is performed by acute blood withdrawal, and the volume of blood to be collected is calculated using the following formula: ANH volume = (patient Hb - target Hb) / mean Hb × blood volume, Instead of the volume of blood withdrawn, crystalloid replacement will be administered at a ratio of 3:1 relative to the volume of blood withdrawn. During these procedures, the mean arterial pressure will be maintained at 65 mmHg. If it drops, blood collection will be stopped and fluid replacement will continue. Blood withdrawal will be resumed when the mean arterial pressure reaches 65 mmHg.

Group 1 (Conventional Group)

PVI dependant acute normovolemic hemodilution OTHER

ANH is performed by acute blood withdrawal, and the volume of blood to be collected is calculated using the following formula: ANH volume = (patient Hb - target Hb) / mean Hb × blood volume, Instead of the volume of blood withdrawn, a PVI pulse probe will be applied and basal fluid replacement will be administered. A 250 mL crystalloid bolus will be given when PVI exceeds 13. If PVI exceeds 15, blood withdrawal will be temporarily discontinued and fluid replacement will be continued until the PVI decreases. During these procedures, the mean arterial pressure will be maintained at 65 mmHg. If it drops, blood collection will be stopped and fluid replacement will continue. Blood withdrawal will be resumed when the mean arterial pressure reaches 65 mmHg.

Group 2 (PVI Group)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa City Hospital: lead

Study Sites (1)

Bursa City Hospital

Bursa, Nilüfer, 16110, Turkey (Türkiye)

Location

Related Publications (1)

• 1. C. Boer, M.I. Meesters, M. Milojevic, et al., 2017 EACTS/EACTA Guidelines on patient blood ma-nagement for adult cardiac surgery, J. Cardiothorac. Vasc. Anesth. 32 (1) (2018) 88-120 2. S.A. Kozek-Langenecker, A.B. Ahmed, A. Afshari, et al., Management of severe perioperative blee-ding: guidelines from the European Society of Anaesthesiology First update 2016, Eur. J. Anaesthe-siol. 34 (6) (2017) 332-395. 3. Monaco F, ANH Study Group. A Randomized Trial of Acute Normovolemic Hemodilution in Car-diac Surgery. N Engl J Med. 2025 Jun 12. Epub ahead of print. PMID: 40503713. 4. Cannesson M, Desebbe O, Rosamel P, et al. Pleth variability index to monitor the respiratory varia-tions in the plethysmographic waveform amplitude and predict fluid responsiveness in mechanically ventilated patients. Anesthesiology. 2008;108(3):664-671. 5. Mathew PJ, Sharma S. Goal-directed fluid therapy guided by Plethysmographic Variability Index (PVI) versus conventional liberal fluid administration in children during elective abdominal sur-gery: A randomized controlled trial. J Pediatr Surg. 2023 Apr;58(4):735-740. Epub 2022 Dec 16. PMID: 36631313. 6. Hasta Kan Yönetimi Rehberi: Modül 2- Perioperatif. 3.6.5. Akut normovolemik hemodilüsyon (ANH). Sayfa 76-78

  BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 12, 2026
• Study Start: November 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 6, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)