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

NCT03940144 | Completed DMC

• 1 other identifier: PX2018007
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Goal-directed Fluid Therapy

Outcome Measures

Primary Outcomes (2)

• Length of hospital stay

  from the end of surgery to discharge from hospital

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

• GI function

  number of participants with I-FEED score \>6

  from the end of surgery to 30 days after surgery

Secondary Outcomes (4)

• mortality

  from the end of surgery to 1 year after surgery

• postoperative pain score

  1 day, 3 days and 5 days after surgery

• postoperative recovery quality

  1 day, 3 days and 5 days after surgery

• Postoperative complications

  from end of surgery to 30 days after surgery

Study Arms (2)

goal-directed fluid therapy

EXPERIMENTAL

Stroke Volume variation (SVV)-guided fluid therapy

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

Conventional fluid therapy

ACTIVE COMPARATOR

Conventional fluid therapy such as CVP and MAP guided fluid therapy

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

Interventions

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

Stroke volume variation (SVV)-guided fluid therapy

Conventional fluid therapy; goal-directed fluid therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• Sun Y, Liang X, Chai F, Shi D, Wang Y. Goal-directed fluid therapy using stroke volume variation on length of stay and postoperative gastrointestinal function after major abdominal surgery-a randomized controlled trial. BMC Anesthesiol. 2023 Dec 4;23(1):397. doi: 10.1186/s12871-023-02360-1.

  PMID: 38049713 DERIVED

Study Officials

• Yanxia Sun, M.D.

  Beijing Tong Ren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: staff anesthesiologist

Model Details: goal-directed fluid therapy guided by stroke volume variation and cardiac index using FloTrac/Vigileo monitor

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 7, 2019
• Study Start: May 15, 2019
• Primary Completion: January 31, 2021
• Study Completion: February 2, 2021
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)