Stroke Volume Variation-guided Fluid Infusion in Major Liver Tumour Resection
Primary Purpose
Fluid Management
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
SVV-guided fluid management
Sponsored by
About this trial
This is an interventional treatment trial for Fluid Management focused on measuring Stroke volume variation, Fluid therapy, Hepatectomy, Alanine aminotransferase, Estimated glomerular filtration rate
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Kaohsiung Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
the low-SVV group
the high-SVV group
Arm Description
the value of stroke volume variation will be less than or equal to 10 this group
the value of stroke volume variation will be higher than 10 this group
Outcomes
Primary Outcome Measures
The incidence of postoperative complications in the two groups.
calculate the incidence of postoperative complication within 30 days
Secondary Outcome Measures
The differences of perioperative ALT
Calculate the difference of the perioperative physiological variables
The differences of perioperative eGFR
Calculate the difference of the perioperative physiological variables
The differences of perioperative creatinine
Calculate the difference of the perioperative physiological variables
The differences of perioperative T.bil
Calculate the difference of the perioperative physiological variables
The differences of perioperative Hb
Calculate the difference of the perioperative physiological variables
The differences of perioperative arterial lactate
Calculate the difference of the perioperative physiological variables
The differences of perioperative albumin
Calculate the difference of the perioperative physiological variables
The pain scale
Assessment of postoperative pain scale
Full Information
NCT ID
NCT05361252
First Posted
April 29, 2022
Last Updated
June 28, 2022
Sponsor
Kaohsiung Veterans General Hospital.
1. Study Identification
Unique Protocol Identification Number
NCT05361252
Brief Title
Stroke Volume Variation-guided Fluid Infusion in Major Liver Tumour Resection
Official Title
Restrictive Versus Liberal Stroke Volume Variation-guided Fluid Infusion in Major Liver Tumour Resection: a Prospective Randomised Trial of Perioperative Quality of Care
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Management
Keywords
Stroke volume variation, Fluid therapy, Hepatectomy, Alanine aminotransferase, Estimated glomerular filtration rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the low-SVV group
Arm Type
Active Comparator
Arm Description
the value of stroke volume variation will be less than or equal to 10 this group
Arm Title
the high-SVV group
Arm Type
Active Comparator
Arm Description
the value of stroke volume variation will be higher than 10 this group
Intervention Type
Procedure
Intervention Name(s)
SVV-guided fluid management
Intervention Description
fluid will be guided by value of stroke volume variation
Primary Outcome Measure Information:
Title
The incidence of postoperative complications in the two groups.
Description
calculate the incidence of postoperative complication within 30 days
Time Frame
From day 1 to day 30 after surgery.
Secondary Outcome Measure Information:
Title
The differences of perioperative ALT
Description
Calculate the difference of the perioperative physiological variables
Time Frame
Examination report on the 1st postoperative day.
Title
The differences of perioperative eGFR
Description
Calculate the difference of the perioperative physiological variables
Time Frame
Examination report on the 1st postoperative day.
Title
The differences of perioperative creatinine
Description
Calculate the difference of the perioperative physiological variables
Time Frame
Examination report on the 1st postoperative day.
Title
The differences of perioperative T.bil
Description
Calculate the difference of the perioperative physiological variables
Time Frame
Examination report on the 1st postoperative day.
Title
The differences of perioperative Hb
Description
Calculate the difference of the perioperative physiological variables
Time Frame
Examination report on the 1st postoperative day.
Title
The differences of perioperative arterial lactate
Description
Calculate the difference of the perioperative physiological variables
Time Frame
Examination report on the 1st postoperative day.
Title
The differences of perioperative albumin
Description
Calculate the difference of the perioperative physiological variables
Time Frame
Examination report on the 1st postoperative day.
Title
The pain scale
Description
Assessment of postoperative pain scale
Time Frame
up to three days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan-Yi Chia, Director
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kai-Wei Hsieh, physician
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
We-Yu Chen, physician
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Study Chair
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Stroke Volume Variation-guided Fluid Infusion in Major Liver Tumour Resection
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