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

NCT07466082 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-12

No results posted yet for this study

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

Interventions

OTHER

acute normovolemic hemodilution

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the following formula: ANH volume = (patient Hb - target Hb) / mean Hb × blood volume, Instead of the volume of blood withdrawn, crystalloid replacement will be administered at a ratio of 3:1 relative to the volume of blood withdrawn.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.

OTHER

PVI dependant acute normovolemic hemodilution

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the following formula: ANH volume = (patient Hb - target Hb) / mean Hb × blood volume, Instead of the volume of blood withdrawn, a PVI pulse probe will be applied and basal fluid replacement will be administered.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.

Sponsors & Collaborators

  • Bursa City Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-03-01
Completion
2026-03-06

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07466082 on ClinicalTrials.gov