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Recruiting NCT06905015

NCT06905015 Stroke Volume Variation Versus Central Venous Pressure Guidance for Reducing Perioperative Blood Loss During Open Liver Resection

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Clinical Trial Summary
NCT ID NCT06905015
Status Recruiting
Phase
Sponsor Warangkana Lapisatepun
Condition Liver Tumor; Surgery
Study Type INTERVENTIONAL
Enrollment 74 participants
Start Date 2024-11-25
Primary Completion 2027-12-31

Eligibility & Interventions

Sex All sexes
Min Age 20 Years
Max Age 70 Years
Study Type INTERVENTIONAL
Interventions
High stroke volume variation group

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 74 participants in total. It began in 2024-11-25 with a primary completion date of 2027-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Liver resection is a major surgery that can be associated with significant intraoperative blood loss and blood transfusion. Among high-volume centers, median intraoperative blood loss ranges between 300-800 ml. Excessive blood loss is a strong independent predictor of worsened postoperative outcomes, increasing morbidity and mortality rates by 20%-35%. Additionally, perioperative allogeneic blood transfusions are associated with deleterious outcomes, including tumor recurrence and increased rates of complications and death. The liver is a highly vascular organ with minimal vascular resistance, receiving up to 25% of cardiac output and pooling 20% of the splanchnic blood. Hepatic veins are a common source of venous hemorrhage. The pressure in the hepatic veins is directly correlated with the pressure in the vena cava and reducing cardiac preload results in decreased hepatic vein congestion. Therefore, low central venous pressure anesthesia (typically below 5 mmHg) can reduce the pressure gradient for retrograde venous bleeding, facilitate the outflow of blood from hepatic veins, and decrease blood volume and pressure in the liver. This anesthetic method is the standard technique to minimize blood loss during liver resection. Central venous pressure was the static parameter used to indicate the right ventricular end-diastolic volume index (RVEDI) and was believed to be correlated with volume status. Despite this, central venous pressure did not reliably predict preload responsiveness due to the curvilinear shape of the ventricular pressure-volume curve, which indicates a poor relationship between ventricular filling pressure and volume. Additionally, the placement of a central venous catheter could lead to serious complications such as arterial cannulation, pneumothorax, and infection. Arterial waveform analysis is dynamic hemodynamic monitoring based on the interaction between the heart and lungs in patients with mechanical ventilation. Stroke volume variation (SVV) is one aspect of arterial pressure waveform analysis and is a less invasive alternative technique for guiding preload status and fluid management in patients undergoing major abdominal surgery. In liver resection, several anesthetic methods are used to achieve low central venous pressure (CVP \< 5 mmHg) during the liver parenchymal dissection phase. These methods include intraoperative volume restriction, administration of venodilators or vasodilators, the use of forced diuresis with furosemide, and the implementation of hypovolemic phlebotomy. As mentioned, central venous pressure is a static hemodynamic monitoring parameter and poorly correlates with volume status. Recently, stroke volume variation has been recognized as a good parameter to predict volume status and fluid responsiveness in patients undergoing liver resection. However, no previous publications have studied the efficacy of stroke volume variation monitoring compared with central venous pressure monitoring to reduce perioperative blood loss during open liver resection. The study aimed to compare the efficacy of maintaining high stroke volume variation versus low central venous pressure in reducing perioperative blood loss during the liver transection phase in open liver resection.

Eligibility Criteria

Inclusion Criteria: * All genders, age 18 to 70 years old * American Society of Anesthesiologists (ASA) physical status classification of I-III * The patients who scheduled in elective open liver resection and diagnosed Hepatocellular Carcinoma, Cholangiocarcinoma, Liver metastasis, and Benign malignant tumor. Exclusion Criteria: * Pregnancy * Active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, active coronary artery disease within 6 months prior surgery) * History of significant cerebrovascular disease (Patients with clinically significant stroke/CVA within 6 months prior surgery, severe carotid stenosis) * Renal dysfunction (GFR \< 60 ml/min/1.73 m²) * Abnormal coagulation parameters (INR \>1.5 not on warfarin and/or platelet count \<100,000) * Preoperative autologous blood donation * Tumor size \> 10 cm. * Previous liver resection Withdrawal criteria: * Unresectable tumor * Persistent intraoperative hypotension that cannot be corrected with vasopressors. * Cardiac arrest during operation * Low central venous pressure (CVP \< 5 mmHg) or high stroke volume variation (SVV \>13%) cannot be achieved before and during liver parenchymal transection.

Contact & Investigator

Central Contact

Worakitti Lapisatepun, MD. PhD.

✉ worakitti.l@cmu.ac.th

📞 0910688761

Principal Investigator

Warangkana Lapisatepun, MD. PhD.

PRINCIPAL INVESTIGATOR

Chiang Mai University

Frequently Asked Questions

Who can join the NCT06905015 clinical trial?

This trial is open to participants of all sexes, aged 20 Years or older, up to 70 Years, studying Liver Tumor; Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06905015 currently recruiting?

Yes, NCT06905015 is actively recruiting participants. Contact the research team at worakitti.l@cmu.ac.th for enrollment information.

Where is the NCT06905015 trial being conducted?

This trial is being conducted at Chiang Mai, Thailand.

Who is sponsoring the NCT06905015 clinical trial?

NCT06905015 is sponsored by Warangkana Lapisatepun. The principal investigator is Warangkana Lapisatepun, MD. PhD. at Chiang Mai University. The trial plans to enroll 74 participants.

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