Acute Normovolemic HemodilutionNCT07466082
Impact of Pleth Variability Index-Guided Acute Normovolemic Hemodilution on Intraoperative Fluid Management and Postoperative Complications in Cardiac Surgery
A study testing acute normovolemic hemodilution and PVI dependant acute normovolemic hemodilution in people with Acute Normovolemic Hemodilution and Cardiac Surgery, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Normovolemic Hemodilution, Cardiac Surgery, Postoperative Complication
- What is being tested?
- acute normovolemic hemodilution and PVI dependant acute normovolemic hemodilution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 6 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- coagulopathy,
- uncontrolled systemic diseases,
- pregnancy,
- malignancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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,
or is determined according to clinical interpretation of hemodynamic parameters [7].
However, ignoring patient-specific physiological responses may limit the effectiveness of ANH. Therefore, the use of a dynamic parameter such as PVI-whose effectiveness has been demonstrated in intraoperative goal-directed fluid therapy-may improve patient safety and enable a more physiological approach to hemodilution.
The primary aim of this study was to evaluate whether performing acute normovolemic hemodilution under PVI guidance during the intraoperative period in cardiac surgery provides more precise volume management. The secondary aim was to assess its effectiveness in reducing allogenic blood transfusion and the risk of complications.
- Conditions
- Acute Normovolemic Hemodilution, Cardiac Surgery, Postoperative Complication, Pleth Variability Index
- Being tested
- acute normovolemic hemodilution, PVI dependant acute normovolemic hemodilution
- Keywords
- acute normovolemic hemodilution, cardiac surgery, Pleth variability index, fluid management
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute normovolemic hemodilutionOther
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.
PVI dependant acute normovolemic hemodilutionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Conventional Group) | Active comparator | In patients undergoing the ANH protocol Receives: Other: acute normovolemic hemodilution |
| Group 2 (PVI Group) | Experimental | In patients undergoing PVI-guided ANH (Masimo SET® and rainbow® Pulse CO-Oximetry) Receives: Other: PVI dependant acute normovolemic hemodilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid management
amount of crystalloid used during procedures
Measured: -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
amount of blood product use
Measured: -intraoperative -postoperative 24.hour
Postoperative Complications
postoperative acute kidney injury, Incidence of AKI based on RIFLE (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease)/KDIGO (Kidney Disease Improving Global Outcomes) criteria within first 24 hours post-op.
Postoperative pulmonary complications were evaluated using the EPCO criteria.
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Nov 2025
- Primary completion1 Mar 2026
- Study completion6 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Normovolemic HemodilutionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, eralp çevikkalp, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466082
- Sponsor's protocol ID
- 2025-KAEK-47
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of ethical and institutional restrictions related to patient confidentiality.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pleth Variability Index-Guided Acute Normovolemic Hemodilution on Intraoperative Fluid Management and Postoperative Complications in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07466082
- Acronym / sponsor ID
- 2025-KAEK-47
- Conditions
- Acute Normovolemic Hemodilution, Cardiac Surgery, Postoperative Complication, Pleth Variability Index
- Keywords
- acute normovolemic hemodilution, cardiac surgery, Pleth variability index, fluid management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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,
or is determined according to clinical interpretation of hemodynamic parameters [7].
However, ignoring patient-specific physiological responses may limit the effectiveness of ANH. Therefore, the use of a dynamic parameter such as PVI-whose effectiveness has been demonstrated in intraoperative goal-directed fluid therapy-may improve patient safety and enable a more physiological approach to hemodilution.
The primary aim of this study was to evaluate whether performing acute normovolemic hemodilution under PVI guidance during the intraoperative period in cardiac surgery provides more precise volume management. The secondary aim was to assess its effectiveness in reducing allogenic blood transfusion and the risk of complications.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Conventional Group) | Active comparator | Other: acute normovolemic hemodilutionIn patients undergoing the ANH protocol |
| Group 2 (PVI Group) | Experimental | Other: PVI dependant acute normovolemic hemodilutionIn patients undergoing PVI-guided ANH (Masimo SET® and rainbow® Pulse CO-Oximetry) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acute normovolemic hemodilutionANH 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 | Group 1 (Conventional Group) |
| PVI dependant acute normovolemic hemodilutionANH 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. | Other | Group 2 (PVI Group) |
Primary outcome
Fluid management
Time frame: -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
2 secondary outcomes
Allogenic Blood Transfusion
Time frame: -intraoperative -postoperative 24.hour
Postoperative Complications
Time frame: postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background1. 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
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of ethical and institutional restrictions related to patient confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acute normovolemic hemodilution and PVI dependant acute normovolemic hemodilution in people with Acute Normovolemic Hemodilution and Cardiac Surgery, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid management (time frame: -during ANH -Total cristalloid amount during surgery -total cristalloid amount during CPB -postoperative cristalloid amount in first 24.hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07466082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.