NCT02507557

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

July 13, 2015

Last Update Submit

July 12, 2016

Conditions

Keywords

Therapy, FluidDigestive System Surgical ProceduresPostoperative Complications

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

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.

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Su Min, MD

    First Affiliated Hospital of Chongqing Medical University

    STUDY CHAIR

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

Locations