NCT02057653

Brief Summary

As part of a quality assurance program, the Department of Anesthesiology implemented a Goal-Directed Fluid Management training course for all physicians and nurses to provide goal-directed fluid management. We intend to assess whether there has been any improvement in patient outcomes by analyzing de-identified clinical information that are readily available via the medical center electronic medical record system. The time-frame we are interested in is one year before and one year after the Goal-Directed Fluid Management training curriculum (June 15, 2011 to September 15, 2013).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

2.9 years

First QC Date

December 17, 2013

Last Update Submit

August 20, 2023

Conditions

Postoperative Complications

Keywords

Goal-directed fluid management

Outcome Measures

Primary Outcomes (1)

  • The difference in length of stay in the hospital after surgery between pre-curriculum and post-curriculum cohorts.

    Length of stay in the hospital (number of nights) after the surgery

    records will be assessed an expected average of 1 year before curriculum (June 2011) and 1 year after curriculum (September 2013) June 15, 2011- September 15, 2013

Secondary Outcomes (10)

  • Incidence of surgical site infection

    30 days after surgery

  • Incidence of postoperative pneumonia

    30 days after surgery

  • Incidence of urinary tract infection

    30 days after surgery

  • Incidence of myocardial infarction

    30 days after surgery

  • Incidence of deep vein thrombosis

    30 days after surgery

  • +5 more secondary outcomes

Study Arms (2)

Before GDFM Training

Approximate 300 patients' medical record information will be extracted from the UC Irvine Medical Center electronic medical record prior to the start of the training curriculum.

After GDFM Training

Approximate 300 patients' medical record information will be extracted from the UC Irvine Medical Center 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

The characteristics for inclusion of the proposed subject population will include those adults patients who have undergone one or more of the following high risk surgeries: liver resection, pancreatectomy, cancer debulking, colorectal surgery, and receive arterial line as directed by the attending anesthesiologist as standard care of patient. Emergent surgical procedures will not be considered for this study.

You may qualify if:

  • Patients aged 18 years or older,
  • Patients undergoing one or more of the following high risk surgeries: liver resection, pancreatectomy, cancer debulking, colorectal surgery,
  • Surgical procedures must be projected to last longer than 2 hours,
  • Patients receiving

You may not qualify if:

  • Pregnant
  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (1)

  • Cannesson M, Ramsingh D, Rinehart J, Demirjian A, Vu T, Vakharia S, Imagawa D, Yu Z, Greenfield S, Kain Z. Perioperative goal-directed therapy and postoperative outcomes in patients undergoing high-risk abdominal surgery: a historical-prospective, comparative effectiveness study. Crit Care. 2015 Jun 19;19(1):261. doi: 10.1186/s13054-015-0945-2.

    PMID: 26088649DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maxime Cannesson, MD, PhD

    UC Irvine Medical Center, Dept. of Anesthesiology & Perioperative Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2013

First Posted

February 7, 2014

Study Start

November 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations

US(1)