Evaluation of Goal-Directed Intraoperative Hemodynamic Optimization Protocol

NCT ID: NCT02057653

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-10-31

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).

Detailed Description

A number of published studies in anesthesia have demonstrated that certain patient factors may impact patient perioperative outcomes. Factors such as age, gender, cardiac function, and hemodynamic status all have been shown to be predictive indicators. The goal of the present study is to evaluate these factors with the effectiveness of the Goal Directed Fluid Management training on patient outcomes after major surgeries and document the final perioperative outcomes.

This is an observational study in which patients' de-identified clinical information will be extracted from the University of California, Irvine Medical Center electronic medical record system to evaluate whether there has been a change in patients' outcomes after the Goal-Directed Fluid Management training curriculum was implemented. We will extract data from both before and after the training took place-- the time-frame is from June 15, 2011 to September 15, 2013. Specifically we will be looking at 30 day re-admission and 90 day mortality following surgery. There are no study procedures or use of biological material. Patient identifies are utilized in the secure database as this is utilized for clinical management. When the data is extracted from the database for research purposes the patient identifiers will be removed and no patient identifiers will be included in the information during statistical analysis or subsequent reporting. For publication, only aggregate data is utilized. No identifiable patient information will be released at any time.

Statistical considerations may include: Sample Size Considerations, Predictors, Covariates/Cofounders, Statistical Goal(s), Statistical Approach, and Secondary Analysis. Specifically, statistical analysis will be performed using computerized software (SPSS for Windows version 12.0). For data that was non-normally distributed a Mann Mann-Whitney test will be used and normally distributed data will be compared using the Student T-test. Ordinal and nominal data will compared using Chi-Square analysis. A p value smaller or equal to 0.05 will be considered significant. These statistical considerations will aid in supporting the study's hypothesis for patient outcomes improvement with Early Goal Directed Fluid Management training.

Conditions

Postoperative Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Pregnant
• Under 18 years of age

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maxime Cannesson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

UC Irvine Medical Center

Orange, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26088649 (View on PubMed)

Other Identifiers

UCIANES04

Identifier Type: OTHER

Identifier Source: secondary_id

20139795

Identifier Type: -

Identifier Source: org_study_id