Effects of Intraoperative Goal-Directed Fluid Therapy on the Incidence of Postoperative Complications
1 other identifier
observational
400
1 country
1
Brief Summary
Excessive fluid loss is often reported in gastrointestinal surgical patients due to preoperative fasting and bowel preparations. Insufficient fluid infusion may cause hypovolemia and tissue hypoperfusion, which may delayed postoperative recovery and even induce postoperative acute renal failure. The aim of this study is to compare the effects of Goal-directed fluid therapy (GDFT) strategy with that of the conventional fluid management on the morbidity and mortality of postoperative complications, length of postoperative hospital stay, and medical expense, so as to provide clinical evidences for optimized intraoperative fluid management for patients undergone gastrointestinal surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2015
CompletedFirst Posted
Study publicly available on registry
July 24, 2015
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 14, 2016
July 1, 2016
6 months
July 13, 2015
July 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The difference in postoperative morbidity rate between pre-training and post-training cohorts
within postoperative 30 days
The difference in postoperative mortality rate between pre-training and post-training cohorts
within postoperative 30 days
Secondary Outcomes (6)
Occurrence of postoperative complications
within postoperative 30 days
Postoperative length of hospital stay
within postoperative 30 days
Readmission rate
within post-discharge 30 days
Time of flatus
within postoperative 30 days
Time of defecation
within postoperative 30 days
- +1 more secondary outcomes
Study Arms (2)
Before GDFM Training
About 200 patients' medical record information will be extracted from the 1st Affiliated Hospital of Chongqing Medical University electronic medical record prior to the start of the training curriculum.
After GDFM Training
About 200 patients' medical record information will be extracted from the 1st Affiliated Hospital of Chongqing Medical University electronic medical record after the training program took place
Eligibility Criteria
patients undergone gastrointestinal surgery
You may qualify if:
- Elective laparotomy or laparoscopic gastrointestinal surgery.
- Age ≥ 18 years old.
- ASA grade II - IV.
- General anesthesia.
You may not qualify if:
- Patients with aortic regurgitation.
- Patients with major artery stenosis disease, peripheral vascular disease and arterial catheterization contraindication.
- Patients with cognitive dysfunction and uncooperative subjects.
- Failure to obtain informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016, China
Related Publications (1)
Jin J, Min S, Liu D, Liu L, Lv B. Clinical and economic impact of goal-directed fluid therapy during elective gastrointestinal surgery. Perioper Med (Lond). 2018 Oct 4;7:22. doi: 10.1186/s13741-018-0102-y. eCollection 2018.
PMID: 30305890DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Su Min, MD
First Affiliated Hospital of Chongqing Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman of department of anesthesiology
Study Record Dates
First Submitted
July 13, 2015
First Posted
July 24, 2015
Study Start
May 1, 2016
Primary Completion
November 1, 2016
Study Completion
December 1, 2016
Last Updated
July 14, 2016
Record last verified: 2016-07