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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02945358
Other study ID # HE581287
Secondary ID
Status Completed
Phase N/A
First received October 24, 2016
Last updated February 28, 2017
Start date September 2016
Est. completion date February 2017

Study information

Verified date February 2017
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A prolonged stay in intensive care unit (ICU) after cardiac surgery with cardiopulmonary bypass increases not only cost of patient care but also morbidity and mortality of patients. The ability to predict which patient has the tendency to have a prolonged ICU stay would help in patient and resource management of the hospital. There are many predictive models aiming at identifying patient at risk of prolonged ICU stay after cardiac surgery with cardiopulmonary bypass but almost all involve the preoperative assessment for proper resource management with one model, Open-Heart Intraoperative Risk (OHIR) Scoring concerning intraoperative manipulatable risk factors to improve anesthetic care and patient outcome. The OHIR model comprises 6 risk factors, 5 of which can be managed intraoperatively, with total score of 7 and a score of ≥ 3 indicating a likely prolonged ICU stay. The objective of this study was to re-validate the performance of OHIR score in the recent context.


Description:

This will be a retrospective, observational, analytical study. The study protocol was approved by the Human Research Ethics Committee, Khon Kaen University (HE581287).

The investigators will review all eligible medical records at Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast, Khon Kaen University during January 2013 and December 2014. The extracted data consist of patient's clinical data and all risk factors in the OHIR score. The investigators will apply the OHIR scoring to the data to assess its performance. The investigators will use the same criteria for a prolonged ICU stay as in the previous study, i.e. a stay longer that the median.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- patients aged 18-75 undergoing cardiac surgery, both CABG and valvular surgery, with the use of cardiopulmonary bypass.

Exclusion Criteria:

- patients having emergency surgery; receiving special devices such as intra-aortic balloon pump or extracorporeal membrane oxygenation.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
adult cardiac surgery with cardiopulmonary pump
Open-heart surgery both coronary artery bypass graft (CABG) and valve surgery

Locations

Country Name City State
Thailand Queen Sirikit Heart Center Khon Kaen
Thailand Srinagarind Hospital, Faculty of Medicine, Khon Kaen University Khon Kaen

Sponsors (1)

Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

Almashrafi A, Alsabti H, Mukaddirov M, Balan B, Aylin P. Factors associated with prolonged length of stay following cardiac surgery in a major referral hospital in Oman: a retrospective observational study. BMJ Open. 2016 Jun 8;6(6):e010764. doi: 10.1136/ — View Citation

Almashrafi A, Elmontsri M, Aylin P. Systematic review of factors influencing length of stay in ICU after adult cardiac surgery. BMC Health Serv Res. 2016 Jul 29;16:318. doi: 10.1186/s12913-016-1591-3. — View Citation

Gruenberg DA, Shelton W, Rose SL, Rutter AE, Socaris S, McGee G. Factors influencing length of stay in the intensive care unit. Am J Crit Care. 2006 Sep;15(5):502-9. Review. — View Citation

Hein OV, Birnbaum J, Wernecke K, England M, Konertz W, Spies C. Prolonged intensive care unit stay in cardiac surgery: risk factors and long-term-survival. Ann Thorac Surg. 2006 Mar;81(3):880-5. — View Citation

Nakasuji M, Matsushita M, Asada A. Risk factors for prolonged ICU stay in patients following coronary artery bypass grafting with a long duration of cardiopulmonary bypass. J Anesth. 2005;19(2):118-23. — View Citation

Tribuddharat S, Sathitkarnmanee T, Ngamsangsirisup K, Charuluxananan S, Hurst CP, Silarat S, Lertmemongkolchai G. Development of an open-heart intraoperative risk scoring model for predicting a prolonged intensive care unit stay. Biomed Res Int. 2014;2014 — View Citation

Williams TA, Ho KM, Dobb GJ, Finn JC, Knuiman M, Webb SA; Royal Perth Hospital ICU Data Linkage Group.. Effect of length of stay in intensive care unit on hospital and long-term mortality of critically ill adult patients. Br J Anaesth. 2010 Apr;104(4):459 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intensive care stay number of hours admitted in ICU through study completion, an average of 1 week
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