Evaluation of Goal-Directed Intraoperative Hemodynamic Optimization Protocol

Postoperative Complications Clinical Trial

Official title:

Evaluation of Goal-Directed Intraoperative Hemodynamic Optimization Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057653
• Other study ID #: 20139795
• Secondary ID: UCIANES04
• Status: Completed
• Start date: November 2013
• Est. completion date: October 2016

Study information

• Verified date: August 2023
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Locations

Country	Name	City	State
United States	UC Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of surgical site infection	Surgical site infection defined according to the NSQIP database	30 days after surgery
Secondary	Incidence of postoperative pneumonia	Pneumonia defined according to the NSQIP database	30 days after surgery
Secondary	Incidence of urinary tract infection	Urinary tract infection defined according to the NSQIP database	30 days after surgery
Secondary	Incidence of myocardial infarction	Myocardial infarction defined according to the NSQIP database	30 days after surgery
Secondary	Incidence of deep vein thrombosis	Deep vein thrombosis defined according to the NSQIP database	30 days after surgery
Secondary	Incidence of atrial fibrillation	Atrial fibrillation defined according to the NSQIP database	30 days after surgery
Secondary	Incidence of sepsis	Sepsis defined according to the NSQIP database	30 days after surgery
Secondary	30 days readmission rate	Unplanned readmission within 30 days after hospital discharge.	30 days after discharge from hospital
Secondary	Incidence of intraoperative transfusion	Blood product transfusion during surgery	intraoperatively (Day 1, during surgery)
Secondary	Incidence of post anesthesia care unit transfusion	Blood product transfusion in the post anesthesia care unit (PACU)	30 days after surgery in the PACU