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Clinical Trials/NCT03940144
NCT03940144
Completed
Not Applicable

Department of Anesthesiology, Beijing Tong Ren Hospital Capital Medical University

Beijing Tongren Hospital1 site in 1 country110 target enrollmentMay 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Goal-directed Fluid Therapy
Sponsor
Beijing Tongren Hospital
Enrollment
110
Locations
1
Primary Endpoint
Length of hospital stay
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2019
End Date
February 2, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Beijing Tongren Hospital
Responsible Party
Principal Investigator
Principal Investigator

YANXIA SUN

staff anesthesiologist

Beijing Tongren Hospital

Eligibility Criteria

Inclusion Criteria

  • Adult patients (aged 18 to 80 years)
  • 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

Outcomes

Primary Outcomes

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

GI function

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

number of participants with I-FEED score \>6

Secondary Outcomes

  • postoperative recovery quality(1 day, 3 days and 5 days after surgery)
  • Postoperative complications(from end of surgery to 30 days after surgery)
  • mortality(from the end of surgery to 1 year after surgery)
  • postoperative pain score(1 day, 3 days and 5 days after surgery)

Study Sites (1)

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