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Effects of Intraoperative Goal-Directed Fluid Therapy on the Incidence of Postoperative Complications

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ClinicalTrials.gov Identifier: NCT02507557
Recruitment Status : Recruiting
First Posted : July 24, 2015
Last Update Posted : July 14, 2016
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Min Su, First Affiliated Hospital of Chongqing Medical University

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.

Condition or disease
Postoperative Complications

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 400 participants
Time Perspective: Retrospective
Official Title: Effects of Intraoperative Goal-Directed Fluid Therapy on the Incidence of Postoperative Complications Following Gastrointestinal Surgery
Study Start Date : May 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Group/Cohort
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



Primary Outcome Measures :
  1. The difference in postoperative morbidity rate between pre-training and post-training cohorts [ Time Frame: within postoperative 30 days ]
  2. The difference in postoperative mortality rate between pre-training and post-training cohorts [ Time Frame: within postoperative 30 days ]

Secondary Outcome Measures :
  1. Occurrence of postoperative complications [ Time Frame: within postoperative 30 days ]
  2. Postoperative length of hospital stay [ Time Frame: within postoperative 30 days ]
  3. Readmission rate [ Time Frame: within post-discharge 30 days ]
  4. Time of flatus [ Time Frame: within postoperative 30 days ]
  5. Time of defecation [ Time Frame: within postoperative 30 days ]
  6. Time of urine catheter removal [ Time Frame: within postoperative 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergone gastrointestinal surgery
Criteria

Inclusion Criteria:

  1. Elective laparotomy or laparoscopic gastrointestinal surgery.
  2. Age ≥ 18 years old.
  3. ASA grade II - IV.
  4. General anesthesia.

Exclusion Criteria:

  1. Patients with aortic regurgitation.
  2. Patients with major artery stenosis disease, peripheral vascular disease and arterial catheterization contraindication.
  3. Patients with cognitive dysfunction and uncooperative subjects.
  4. Failure to obtain informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507557


Contacts
Contact: Juying Jin, Doctor +86-13527486171 juyingjin@Hotmail.com
Contact: Su Min, MD +86-023-89011068 ms89011068@163.com

Locations
China
The First Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, China, 400016
Contact: Juying Jin, M.D.    086-023-89011069    juyingjin@hotmail.com   
Sponsors and Collaborators
First Affiliated Hospital of Chongqing Medical University
Edwards Lifesciences
Investigators
Study Chair: Su Min, MD First Affiliated Hospital of Chongqing Medical University

Responsible Party: Min Su, Chairman of department of anesthesiology, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT02507557     History of Changes
Other Study ID Numbers: GDFTCQ2015
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Min Su, First Affiliated Hospital of Chongqing Medical University:
Therapy, Fluid
Digestive System Surgical Procedures
Postoperative Complications

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes