Department of Anesthesiology, Beijing Tong Ren Hospital Capital Medical University
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Length of hospital stay
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Care providers and investigators in the operating room could not be blinded due to the presence of the cardiac index trending monitor. The postoperative assessors were blinded to the allocation.
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
YANXIA SUN
staff anesthesiologist
Beijing Tongren Hospital