Postoperative ComplicationsNCT02057653
Evaluation of Goal-Directed Intraoperative Hemodynamic Optimization Protocol
An observational study of Postoperative Complications, run by University of California, Irvine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnant
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Keywords
- Goal-directed fluid management
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Surgical site infection defined according to the NSQIP database
Measured: 30 days after surgery
Incidence of postoperative pneumonia
Pneumonia defined according to the NSQIP database
Measured: 30 days after surgery
Incidence of urinary tract infection
Urinary tract infection defined according to the NSQIP database
Measured: 30 days after surgery
Incidence of myocardial infarction
Myocardial infarction defined according to the NSQIP database
Measured: 30 days after surgery
Incidence of deep vein thrombosis
Deep vein thrombosis defined according to the NSQIP database
Measured: 30 days after surgery
Incidence of atrial fibrillation
Atrial fibrillation defined according to the NSQIP database
Measured: 30 days after surgery
Incidence of sepsis
Sepsis defined according to the NSQIP database
Measured: 30 days after surgery
30 days readmission rate
Unplanned readmission within 30 days after hospital discharge.
Measured: 30 days after discharge from hospital
Incidence of intraoperative transfusion
Blood product transfusion during surgery
Measured: intraoperatively (Day 1, during surgery)
Incidence of post anesthesia care unit transfusion
Blood product transfusion in the post anesthesia care unit (PACU)
Measured: 30 days after surgery in the PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime Cannesson, MD, PhD, Principal investigator, UC Irvine Medical Center, Dept. of Anesthesiology & Perioperative Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057653
- Sponsor's protocol ID
- 20139795
- Other IDs
- UCIANES04
- Status last verified
- Aug 2023
- First submitted
- 17 Dec 2013
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26088649
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Goal-Directed Intraoperative Hemodynamic Optimization Protocol
- ClinicalTrials.gov ID
- NCT02057653
- Acronym / sponsor ID
- 20139795
- Conditions
- Postoperative Complications
- Keywords
- Goal-directed fluid management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 7 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
Incidence of surgical site infection
Time frame: 30 days after surgery
Incidence of postoperative pneumonia
Time frame: 30 days after surgery
Incidence of urinary tract infection
Time frame: 30 days after surgery
Incidence of myocardial infarction
Time frame: 30 days after surgery
Incidence of deep vein thrombosis
Time frame: 30 days after surgery
Incidence of atrial fibrillation
Time frame: 30 days after surgery
Incidence of sepsis
Time frame: 30 days after surgery
30 days readmission rate
Time frame: 30 days after discharge from hospital
Incidence of intraoperative transfusion
Time frame: intraoperatively (Day 1, during surgery)
Incidence of post anesthesia care unit transfusion
Time frame: 30 days after surgery in the PACU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Derived from this study: PubMed 26088649Cannesson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime Cannesson, MD, PhD principal investigator
UC Irvine Medical Center, Dept. of Anesthesiology & Perioperative Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02057653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.