Clinical trial NCT05361252: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Management
Keywords: Stroke volume variation
Fluid therapy
Hepatectomy
Alanine aminotransferase
Estimated glomerular filtration rate
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 118
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The incidence of postoperative complications in the two groups.
timeFrame: From day 1 to day 30 after surgery.
Secondary outcomes:
measure: The differences of perioperative ALT
timeFrame: Examination report on the 1st postoperative day.
measure: The differences of perioperative eGFR
timeFrame: Examination report on the 1st postoperative day.
measure: The differences of perioperative creatinine
timeFrame: Examination report on the 1st postoperative day.
measure: The differences of perioperative T.bil
timeFrame: Examination report on the 1st postoperative day.
measure: The differences of perioperative Hb
timeFrame: Examination report on the 1st postoperative day.
measure: The differences of perioperative arterial lactate
timeFrame: Examination report on the 1st postoperative day.
measure: The differences of perioperative albumin
timeFrame: Examination report on the 1st postoperative day.
measure: The pain scale
timeFrame: up to three days postoperatively
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Yuan-Yi Chia, Director
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaohsiung Veterans General Hospital.
name: Kai-Wei Hsieh, physician
role: STUDY_DIRECTOR
affiliation: Kaohsiung Veterans General Hospital.
name: We-Yu Chen, physician
role: STUDY_CHAIR
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