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

Study Overview
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Brief Summary
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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.

Official Title
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Restrictive Versus Liberal Stroke Volume Variation-guided Fluid Infusion in Major Liver Tumour Resection: a Prospective Randomised Trial of Perioperative Quality of Care

Conditions
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Fluid Management

Intervention / Treatment
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* Procedure: SVV-guided fluid management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the low-SVV group<br>the value of stroke volume variation will be less than or equal to 10 this group | Procedure: SVV-guided fluid management<br>* fluid will be guided by value of stroke volume variation<br>|
| Active Comparator: the high-SVV group<br>the value of stroke volume variation will be higher than 10 this group | Procedure: SVV-guided fluid management<br>* fluid will be guided by value of stroke volume variation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences of perioperative ALT | Calculate the difference of the perioperative physiological variables | Examination report on the 1st postoperative day. | 
| The differences of perioperative eGFR | Calculate the difference of the perioperative physiological variables | Examination report on the 1st postoperative day. | 
| The differences of perioperative creatinine | Calculate the difference of the perioperative physiological variables | Examination report on the 1st postoperative day. | 
| The differences of perioperative T.bil | Calculate the difference of the perioperative physiological variables | Examination report on the 1st postoperative day. | 
| The differences of perioperative Hb | Calculate the difference of the perioperative physiological variables | Examination report on the 1st postoperative day. | 
| The differences of perioperative arterial lactate | Calculate the difference of the perioperative physiological variables | Examination report on the 1st postoperative day. | 
| The differences of perioperative albumin | Calculate the difference of the perioperative physiological variables | Examination report on the 1st postoperative day. | 
| The pain scale | Assessment of postoperative pain scale | up to three days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke volume variation, Fluid therapy, Hepatectomy, Alanine aminotransferase, Estimated glomerular filtration rate