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Completed

NCT Number: NCT05361252

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

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.

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Key information

Conditions

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SVV-guided fluid management

Procedure

fluid will be guided by value of stroke volume variation

Primary outcomes

  1. The incidence of postoperative complications in the two groups.

    Time frame: From day 1 to day 30 after surgery.

    calculate the incidence of postoperative complication within 30 days

Secondary outcomes

  1. The differences of perioperative ALT

    Time frame: Examination report on the 1st postoperative day.

    Calculate the difference of the perioperative physiological variables

  2. The differences of perioperative eGFR

    Time frame: Examination report on the 1st postoperative day.

    Calculate the difference of the perioperative physiological variables

  3. The differences of perioperative creatinine

    Time frame: Examination report on the 1st postoperative day.

    Calculate the difference of the perioperative physiological variables

  4. The differences of perioperative T.bil

    Time frame: Examination report on the 1st postoperative day.

    Calculate the difference of the perioperative physiological variables

  5. The differences of perioperative Hb

    Time frame: Examination report on the 1st postoperative day.

    Calculate the difference of the perioperative physiological variables

  6. The differences of perioperative arterial lactate

    Time frame: Examination report on the 1st postoperative day.

    Calculate the difference of the perioperative physiological variables

  7. The differences of perioperative albumin

    Time frame: Examination report on the 1st postoperative day.

    Calculate the difference of the perioperative physiological variables

  8. The pain scale

    Time frame: up to three days postoperatively

    Assessment of postoperative pain scale

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 4, 2022
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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