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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03940144

Recruitment Status Not yet recruiting

First Posted May 7, 2019

Last update posted May 7, 2019

Study Description

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

  • Condition or Disease:Postoperative Complications
  • Intervention/Treatment: Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device
  • Phase: N/A
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
  • Estimated Enrollment: 100 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Department of Anesthesiology, Beijing Tong Ren Hospital Capital Medical University
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: January 2020
  • Estimated Study Completion Date: August 2020
Arms and interventions
Arm Intervention/treatment
Active Comparator: Conventional fluid therapy
Conventional fluid therapy such as CVP, MAP and urine-output guided fluid therapy
Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device
Stroke volume variation (SVV)-guided fluid therapy
Experimental: goal-directed fluid therapy
Stroke Volume variation (SVV)-guided fluid therapy
Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device
Stroke volume variation (SVV)-guided fluid therapy
Outcome Measures
  • Primary Outcome Measures: 1. postoperative morbidity [ Time Frame: one year ]
    any complications after surgery
  • 2. mortality [ Time Frame: from the end of surgery to 1 year after surgery ]
    death after surgery
  • Secondary Outcome Measures: 1. length of hospital stay [ Time Frame: one year ]
    from the end of surgery to discharge from hospital
Eligibility Criteria
  • Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- adult patients (aged 16 years or older) undergoing major abdominal surgery were
evaluated. Major abdominal surgery was defined using the Physiological and Operative
Severity Score for the Enumeration of Mortality and Morbidity (POSSUM)

Exclusion Criteria:

- pediatric patients, other type-surgical patients, or postoperative patients with
already established sepsis or organ failure and undergoing late optimization were
excluded

Contacts and Locations
Contacts

Contact: Yanxia Sun, M.D. +8613611389939 sun00017@gmail.com

Contact: Xuan Liang, M.D. 8613810261846 doctor_xuan@hotmail.com

Locations
Sponsors and Collaborators

Beijing Tongren Hospital

Investigators

Principal Investigator: Yanxia Sun, M.D. Beijing Tong Ren Hospital

More Information
  • Responsible Party: Beijing Tongren Hospital
  • ClinicalTrials.gov Identifier: NCT03940144 History of Changes
  • Other Study ID Numbers: PX2018007
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 7, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Postoperative Complications