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Completed

NCT Number: NCT03940144

Effect of SVV-guided Fluid Therapy on Outcomes After Major Abdominal Surgery

The investigators conduct this randomized assessor-blinded controlled trial to evaluate the effect of SVV-guided fluid therapy on postoperative morbidity and mortality in comparison with conventional fluid therapy after major abdominal surgery. Half of participants will receive GDFT perioperatively, and the others will receive conventional fluid therapy

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

About this study

Perioperative fluid management has been recognized as an important factor with an impact on postoperative recovery following major abdominal surgery. However, the optimal fluid management is difficult to achieve using standard parameters (e.g., heart rate [HR], blood pressure [BP], central venous pressure[CVP], or urine output) that poorly estimate preload and preload responsiveness. Goal-directed fluid therapy (GDFT) was proposed by introducing different hemodynamic variables into a dynamic perspective of individual fluid loading with or without vasoactive substances to reach predefined goal of optimal preload and/or oxygen delivery.There have been increasing numbers of studies evaluating the effect of perioperative GDFT on postoperative recovery following major abdominal surgery. However, the evidence for the beneficial effect of GDFT on postoperative recovery remains inconsistent.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (aged 18 to 80 years)
  • ASA I~III
  • BMI:18~30kg/m2
  • Procedures were considered major if listed for resection of gastrointestinal, gynecologic, and urologic cancer with tumor debulking, staging or reconstruction with a risk for significant surgical blood loss

Exclusion criteria

  • Patients under 18 years,
  • pregnant or lactating woman
  • patients with esophageal or gastric surgical history
  • co-existing congestive heart failure; chronic lung disease; or renal or hepatic dysfunction (creatinine >50 % or liver enzymes >50 % of normal values), and arrhythmias-operative down staging using chemotherapy and/or radiation therapy
  • patients undergoing emergency surgery
  • patients with co-existing congestive heart failure; chronic lung disease; or renal or hepatic dysfunction (creatinine >50 % or liver enzymes >50 % of normal values), and arrhythmias

Treatment and study plan

the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device

Device

Stroke volume variation (SVV)-guided fluid therapy

Primary outcomes

  1. Length of hospital stay

    Time frame: from the end of surgery to discharge from hospital up to 30 days after surgery

    from the end of surgery to discharge from hospital

  2. GI function

    Time frame: from the end of surgery to 30 days after surgery

    number of participants with I-FEED score >6

Secondary outcomes

  1. mortality

    Time frame: from the end of surgery to 1 year after surgery

    death after surgery

  2. postoperative pain score

    Time frame: 1 day, 3 days and 5 days after surgery

    VAS for pain :0 no pain and 10 for worst pain

  3. postoperative recovery quality

    Time frame: 1 day, 3 days and 5 days after surgery

    QoR-15 :quality of recovery score : 0 worst recovery quality and 150 for best recovery

  4. Postoperative complications

    Time frame: from end of surgery to 30 days after surgery

    number of any complications after surgery

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

Department of Anesthesiology, Beijing Tong Ren Hospital Capital Medical University

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 7, 2019
Registry last updated
Mar 9, 2023

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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