Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Goal-Directed Intraoperative Hemodynamic Optimization Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057653
Recruitment Status : Unknown
Verified February 2016 by Maxime Cannesson, University of California, Irvine.
Recruitment status was:  Recruiting
First Posted : February 7, 2014
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Maxime Cannesson, University of California, Irvine

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).

Condition or disease
Postoperative Complications

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Goal-Directed Intraoperative Hemodynamic Optimization Protocol
Study Start Date : November 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Group/Cohort
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



Primary Outcome Measures :
  1. The difference in length of stay in the hospital after surgery between pre-curriculum and post-curriculum cohorts. [ Time Frame: 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 ]
    Length of stay in the hospital (number of nights) after the surgery


Secondary Outcome Measures :
  1. Incidence of surgical site infection [ Time Frame: 30 days after surgery ]
    Surgical site infection defined according to the NSQIP database

  2. Incidence of postoperative pneumonia [ Time Frame: 30 days after surgery ]
    Pneumonia defined according to the NSQIP database

  3. Incidence of urinary tract infection [ Time Frame: 30 days after surgery ]
    Urinary tract infection defined according to the NSQIP database

  4. Incidence of myocardial infarction [ Time Frame: 30 days after surgery ]
    Myocardial infarction defined according to the NSQIP database

  5. Incidence of deep vein thrombosis [ Time Frame: 30 days after surgery ]
    Deep vein thrombosis defined according to the NSQIP database

  6. Incidence of atrial fibrillation [ Time Frame: 30 days after surgery ]
    Atrial fibrillation defined according to the NSQIP database

  7. Incidence of sepsis [ Time Frame: 30 days after surgery ]
    Sepsis defined according to the NSQIP database

  8. 30 days readmission rate [ Time Frame: 30 days after discharge from hospital ]
    Unplanned readmission within 30 days after hospital discharge.

  9. Incidence of intraoperative transfusion [ Time Frame: intraoperatively (Day 1, during surgery) ]
    Blood product transfusion during surgery

  10. Incidence of post anesthesia care unit transfusion [ Time Frame: 30 days after surgery in the PACU ]
    Blood product transfusion in the post anesthesia care unit (PACU)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
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.
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

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): NCT02057653


Contacts
Layout table for location contacts
Contact: Maxime Cannesson, MD, PhD (714) 456-8869; 6652 mcanness@uci.edu
Contact: Davinder Ramsingh, MD dramsing@uci.edu

Locations
Layout table for location information
United States, California
UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Cecilia Canales, MPH    714-456-8998    canalesc@uci.edu   
Sub-Investigator: Joseph Rinehart, MD         
Sub-Investigator: Cameron Ricks, MD         
Sub-Investigator: Shermeen Vakharia, MD         
Sub-Investigator: Trung Vu, MD         
Sub-Investigator: Cecilia Canales, MPH         
Sub-Investigator: Davinder Ramsingh, MD         
Sponsors and Collaborators
University of California, Irvine
Investigators
Layout table for investigator information
Principal Investigator: Maxime Cannesson, MD, PhD UC Irvine Medical Center, Dept. of Anesthesiology & Perioperative Care
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Maxime Cannesson, Associate Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02057653    
Other Study ID Numbers: UCIANES04
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Keywords provided by Maxime Cannesson, University of California, Irvine:
Goal-directed fluid management
Additional relevant MeSH terms:
Layout table for MeSH terms
Postoperative Complications
Pathologic Processes