Stroke Volume Variation-guided Fluid Infusion in Major Liver Tumour Resection

NCT05361252 | Completed

• 1 other identifier: VGHKS16-CT8-25
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Studies have demonstrated that the rate of change in stroke volume variation (SVV) can be used to determine the volume of body fluids during major abdominal surgery. Anaesthesiologists can use SVV as a guide for the appropriate administration of intraoperative fluids to improve postoperative prognoses. Liver surgery is a major abdominal operation, and the amount of blood lost is typically higher than that during other general abdominal surgeries. Blood loss is positively correlated with the intraoperative fluid infusion volume, and greater blood loss is associated with more postoperative complications. Additionally, comorbid liver disease or cirrhosis can increase the complexity of liver tumour resection, causing difficulty in assessing intravascular volume and determining the appropriate intraoperative infusion volume.

Conditions

Fluid Management

Keywords

Stroke volume variation; Fluid therapy; Hepatectomy; Alanine aminotransferase; Estimated glomerular filtration rate

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative complications in the two groups.

  calculate the incidence of postoperative complication within 30 days

  From day 1 to day 30 after surgery.

Secondary Outcomes (8)

• The differences of perioperative ALT

  Examination report on the 1st postoperative day.

• The differences of perioperative eGFR

  Examination report on the 1st postoperative day.

• The differences of perioperative creatinine

  Examination report on the 1st postoperative day.

• The differences of perioperative T.bil

  Examination report on the 1st postoperative day.

• The differences of perioperative Hb

  Examination report on the 1st postoperative day.

Study Arms (2)

the low-SVV group

ACTIVE COMPARATOR

the value of stroke volume variation will be less than or equal to 10 this group

Procedure: SVV-guided fluid management

the high-SVV group

ACTIVE COMPARATOR

the value of stroke volume variation will be higher than 10 this group

Procedure: SVV-guided fluid management

Interventions

SVV-guided fluid management PROCEDURE

fluid will be guided by value of stroke volume variation

the high-SVV group; the low-SVV group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We initially selected 118 patients who required hepatectomy.
• The physiological status of the patients was assessed in terms of American Society of Anesthesiologists scores I-III

You may not qualify if:

• Extreme body mass index (BMI)
• Age under 20 or over 75 years
• Emergency surgery
• Preexisting cardiac, hepatic, renal, or coagulation disorder; hyperthyroidism; and sinus arrhythmia.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Related Publications (26)

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Study Officials

• Yuan-Yi Chia, Director

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

• Kai-Wei Hsieh, physician

  Kaohsiung Veterans General Hospital.

  STUDY DIRECTOR

• We-Yu Chen, physician

  Kaohsiung Veterans General Hospital.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Anesthesiology

Model Details: This trial had a randomised study design with simple randomisation and a fixed allocation ratio (1:1 to the low-SVV group or high-SVV group). The patients were blinded to the randomisation and allocation.

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: February 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)