Clinical trial NCT03940144: Effect of SVV-guided Fluid Therapy on Outcomes After Major Abdominal Surgery
Official title: Department of Anesthesiology, Beijing Tong Ren Hospital Capital Medical University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Goal-directed Fluid Therapy
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: goal-directed fluid therapy guided by stroke volume variation and cardiac index using FloTrac/Vigileo monitor
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients (aged 18 to 80 years)
2. ASA I\~III
3. BMI:18\~30kg／m2
4. 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:

1. Patients under 18 years,
2. pregnant or lactating woman
3. patients with esophageal or gastric surgical history
4. 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
5. patients undergoing emergency surgery
6. 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

Primary outcomes:
measure: Length of hospital stay
timeFrame: from the end of surgery to discharge from hospital up to 30 days after surgery
measure: GI function
timeFrame: from the end of surgery to 30 days after surgery
Secondary outcomes:
measure: mortality
timeFrame: from the end of surgery to 1 year after surgery
measure: postoperative pain score
timeFrame: 1 day, 3 days and 5 days after surgery
measure: postoperative recovery quality
timeFrame: 1 day, 3 days and 5 days after surgery
measure: Postoperative complications
timeFrame: from end of surgery to 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
affiliation: Beijing Tong Ren Hospital
name: Yanxia Sun, M.D.
role: PRINCIPAL_INVESTIGATOR
References: