Peri-operative Prediction of Prolonged Stay in the Cardiac Intensive Care Unit for Adult Cardiac Surgery

Completed

• Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery; Cytokine Release Syndrome

• Registration Number: NCT01559870
• Lead Sponsor: Thepakorn Sathitkarnmanee

Brief Summary

The purpose of this study is to create a model using intra-operative modified SOFA score and peri-operative clinical factors to predict prolonged stay in the cardiac intensive care unit (CICU) for adult cardiac surgery with heart-lung machine

Detailed Description

Cardiac surgery using cardiopulmonary bypass (CPB) is commonly associated with a systemic inflammatory response that exacerbates peri-operative life-threatening complications and multiple organ dysfunction syndromes. These features can prolong the stay in the CICU. Many peri-operative clinical risk factors contribute to those adverse outcomes resulting in prolonged CICU stay. If the investigators can create a model to identify the effects of these intra-operative clinical risk factors to prolonged CICU stay

Study Timeline

• Study Start: 2011-08
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-21
• Study Completion: 2012-08
• Last Update Submitted: 2012-11-10
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• adult patients who had undergone elective cardiac surgery with CPB

Exclusion Criteria

• under 18 years of age
• needing emergency surgery
• needing intra-aortic balloon pump

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adjusted odds ratio of peri-operative clinical risk factors in prolonged CICU patients	24 hours after CPB	Blood samples were collected for cytokines investigation and leukocyte counts. Clinical scoring systems , major peri-operative clinical risk factors were calculated and recorded at each time point. Univariate odds ratio were calculated for each factors for prolonged CICU stay. Those significant factors were included in logistic regression model for analysis of adjusted odds ratios. Then, a model for prolonged CICU stay is constructed.

Trial Locations

Locations (2)

Queen Sirikit Heart Cenrter; 🇹🇭 Khon Kaen, Thailand

Queen Sirikit Heart Center; 🇹🇭 Khon Kaen, Thailand