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

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

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 164

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Queen Sirikit Heart Center
  • Khon Kaen, Thailand, 40002
    • Queen Sirikit Heart Cenrter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult patients who had undergone elective cardiac surgery with CPB

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patients with elective cardiac surgery; adult patients who had undergone elective cardiac surgery with CPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted odds ratio of peri-operative clinical risk factors in prolonged CICU patients	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.	24 hours after CPB

Collaborators and Investigators

• Sponsor: Thepakorn Sathitkarnmanee
• Collaborators: Khon Kaen University

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 13, 2012
• First Submitted That Met QC Criteria: March 20, 2012
• First Posted (Estimate): March 21, 2012

Study Record Updates

• Last Update Posted (Estimate): November 14, 2012
• Last Update Submitted That Met QC Criteria: November 10, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: cardiac surgery; cytokine; risk factor; clinical scoring system
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Cytokine Release Syndrome
• Other Study ID Numbers: HE541122