NCT02945358

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

October 24, 2016

Last Update Submit

February 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intensive care stay

    number of hours admitted in ICU

    through study completion, an average of 1 week

Study Arms (1)

Prolonged ICU stay

Group 1: adult cardiac surgery with cardiopulmonary pump with prolonged ICU stay Group 2: adult cardiac surgery with cardiopulmonary pump with non-prolonged ICU stay

Procedure: adult cardiac surgery with cardiopulmonary pump

Interventions

Open-heart surgery both coronary artery bypass graft (CABG) and valve surgery

Prolonged ICU stay

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing open-heart surgery both CABG and valve surgery with cardiopulmonary pump

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Queen Sirikit Heart Center

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Related Publications (7)

  • 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):459-64. doi: 10.1093/bja/aeq025. Epub 2010 Feb 25.

  • 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. doi: 10.1016/j.athoracsur.2005.09.077.

  • 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. doi: 10.1007/s00540-005-0301-9.

  • 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.

  • 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/bmjopen-2015-010764.

  • 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.

  • 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;2014:158051. doi: 10.1155/2014/158051. Epub 2014 Apr 10.

Study Officials

  • Sirirat Tribuddharat, MD

    Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 26, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations