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Completed

NCT Number: NCT02057653

Evaluation of Goal-Directed Intraoperative Hemodynamic Optimization Protocol

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Irvine Medical Center

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 7, 2014
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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