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

Fluid Management Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05361252
• Other study ID #: VGHKS16-CT8-25
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2022
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fluid Management
• Liver Neoplasms

Intervention

Procedure:
• SVV-guided fluid management
fluid will be guided by value of stroke volume variation

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

References & Publications (26)

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Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. — View Citation

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Sear JW. Kidney dysfunction in the postoperative period. Br J Anaesth. 2005 Jul;95(1):20-32. Epub 2004 Nov 5. Review. — View Citation

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Tavernier B, Makhotine O, Lebuffe G, Dupont J, Scherpereel P. Systolic pressure variation as a guide to fluid therapy in patients with sepsis-induced hypotension. Anesthesiology. 1998 Dec;89(6):1313-21. — View Citation

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Yu LH, Yu WL, Zhao T, Wu MC, Fu XH, Zhang YJ. Post-operative delayed elevation of ALT correlates with early death in patients with HBV-related hepatocellular carcinoma and Post-hepatectomy Liver Failure. HPB (Oxford). 2018 Apr;20(4):321-326. doi: 10.1016/j.hpb.2017.10.001. Epub 2018 Jan 17. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The differences of perioperative ALT	Calculate the difference of the perioperative physiological variables	Examination report on the 1st postoperative day.
Secondary	The differences of perioperative eGFR	Calculate the difference of the perioperative physiological variables	Examination report on the 1st postoperative day.
Secondary	The differences of perioperative creatinine	Calculate the difference of the perioperative physiological variables	Examination report on the 1st postoperative day.
Secondary	The differences of perioperative T.bil	Calculate the difference of the perioperative physiological variables	Examination report on the 1st postoperative day.
Secondary	The differences of perioperative Hb	Calculate the difference of the perioperative physiological variables	Examination report on the 1st postoperative day.
Secondary	The differences of perioperative arterial lactate	Calculate the difference of the perioperative physiological variables	Examination report on the 1st postoperative day.
Secondary	The differences of perioperative albumin	Calculate the difference of the perioperative physiological variables	Examination report on the 1st postoperative day.
Secondary	The pain scale	Assessment of postoperative pain scale	up to three days postoperatively