Actively Recruiting

Phase Not Applicable
Age: 20Years - 70Years
All Genders
ID06905015

Comparison of Stroke Volume Variation Versus Central Venous Pressure Guidance to Reduce Blood Loss During Open Liver Resection: A Randomized Controlled Study

Led by Warangkana Lapisatepun · Updated on 2025-04-01

74

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

W

Warangkana Lapisatepun

Lead Sponsor

C

Chiang Mai University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Liver resection surgery can involve significant blood loss, which increases the risk of complications and death. This trial compares two methods used during open liver resection to reduce blood loss: maintaining a high stroke volume variation (SVV) and keeping a low central venous pressure (CVP). The study aims to determine which method better minimizes perioperative blood loss and improves patient outcomes. Participants will be randomly assigned to one of two groups. In the high SVV group, anesthesiologists will maintain SVV between 13-20% during the liver transection phase using the FloTrac-Vigileo system for fluid management, while CVP monitoring is hidden. In the low CVP group, the anesthesiologists will keep CVP below 5 mmHg during liver transection and use CVP to guide fluids, concealing SVV monitoring. Both methods involve fluid restriction during transection and fluid resuscitation afterward. Throughout the study, researchers will measure blood loss during liver transection and the entire surgery, blood transfusions, surgical bleeding scores, and postoperative complications including kidney injury and liver failure. They will also monitor serum lactate levels, reoperation rates, intensive care and hospital stay lengths, mortality, and 30-day readmission. The study lasts from enrollment through 30 days after surgery, ensuring thorough safety and outcome monitoring.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 70 years
  • All genders
  • American Society of Anesthesiologists (ASA) physical status I to III
  • Scheduled for elective open liver resection
  • Diagnosed with hepatocellular carcinoma, cholangiocarcinoma, liver metastasis, or benign liver tumor
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Active heart conditions such as unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, or recent coronary artery disease within 6 months
  • History of significant stroke or cerebrovascular disease within 6 months
  • Kidney dysfunction with GFR less than 60 ml/min/1.73 m²
  • Abnormal blood clotting (INR over 1.5 without warfarin, or platelet count below 100,000)
  • Previous autologous blood donation
  • Tumor larger than 10 cm
  • Previous liver resection
  • Unresectable tumor found during surgery
  • Persistent low blood pressure during surgery not corrected by medication
  • Inability to achieve target CVP or SVV during liver transection

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of the surgery day

Participants undergo open liver resection surgery during which fluid management is guided by either stroke volume variation (SVV) or central venous pressure (CVP) monitoring to reduce perioperative blood loss.

1 surgical procedure visit

Follow-up

Duration - Up to 30 days post-surgery

Participants are monitored for postoperative outcomes including blood transfusions, complications, length of hospital and ICU stay, and mortality for up to 30 days after surgery.

Approximately 3 to 5 visits or contacts during 30 days

Trial Site Locations

Total: 1 location

1

Department of Anesthesiology, Faculty of Medicine, Chiang Mai University

Chiang Mai, Chiangmai, Thailand, 50200

Actively Recruiting

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Research Team

W

Worakitti Lapisatepun, MD. PhD.

W

Worakitti Lapisatepun, MD.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Stroke volume variation in hepatic resection: a replacement for standard central venous pressure monitoring.

Erik M Dunki-Jacobs, Prejesh Philips, Charles R Scoggins...

https://pubmed.ncbi.nlm.nih.gov/24150192