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

NCT06905015 | Recruiting DMC

• 1 other identifier: ANE-2567-0300
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Tumor; Surgery; Primary Liver Tumor, Metastatic Liver; Primary Liver Cancer; Liver Resection; Benign Liver Tumor

Keywords

Stroke volume variation; central venous pressure; open liver resection; blood loss

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss during parenchymal transection phase and entire operation

  To compare intraoperative blood loss between patients maintained with high stroke volume variation and those maintained with low central venous pressure during open liver resection by assessing: * Blood loss during the liver transection phase * Total blood loss Intraoperative blood loss will be estimated by combining the measured volume of suctioned blood and the measured weight of sponges and gauzes.

  From enrollment to the end of operation

Secondary Outcomes (1)

• Allogenic blood transfusion and postoperative morbidity and mortality rate

  From enrollment to the postoperative day 30

Study Arms (2)

High SVV group

EXPERIMENTAL

High stroke volume variation group: Anesthesiologists will perform methods to achieve and maintain SVV at 13-20% during liver parenchymal transection (fluid restrictive phase). Central venous pressure monitoring will be concealed with drapes, and the room anesthesiologist will use SVV for guiding fluid management.

Device: High stroke volume variation group

Low CVP group

ACTIVE COMPARATOR

Low central venous pressure group: Anesthesiologists will perform methods to maintain CVP under 5 mmHg during liver parenchymal transection (fluid restrictive phase). Stroke volume variation monitoring will be concealed by drapes, and the room anesthesiologist will use CVP to guide fluid management.

Device: High stroke volume variation group

Interventions

High stroke volume variation group DEVICE

Anesthesiologists will perform methods to achieve and maintain SVV at 13-20% during liver parenchymal transection (fluid restrictive phase). Central venous pressure monitoring will be concealed with drapes, and the room anesthesiologist will use SVV for guiding fluid management only during parenchymal transection phase. If SVV exceeds 20%, a balanced salt crystalloid will be administered in the minimal amount necessary to reduce the SVV to below 20%.

High SVV group; Low CVP group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Warangkana Lapisatepun: lead
• Chiang Mai University: collaborator

Study Sites (1)

Department of Anesthesiology, Faculty of Medicine, Chiang Mai University

Chiang Mai, Chiangmai, 50200, Thailand

RECRUITING

Related Publications (1)

• Dunki-Jacobs EM, Philips P, Scoggins CR, McMasters KM, Martin RC 2nd. Stroke volume variation in hepatic resection: a replacement for standard central venous pressure monitoring. Ann Surg Oncol. 2014 Feb;21(2):473-8. doi: 10.1245/s10434-013-3323-9. Epub 2013 Oct 23.

  PMID: 24150192 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hemorrhage

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Warangkana Lapisatepun, MD. PhD.

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Worakitti Lapisatepun, MD. PhD.

CONTACT

0910688761; worakitti.l@cmu.ac.th

Worakitti Lapisatepun, MD.

CONTACT

0910688761; worakitti.l@cmu.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chiang Mai University

Model Details: Noninferiority randomized controlled trials

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: November 25, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)