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

Cytokine Release Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559870
• Other study ID #: HE541122
• Status: Completed
• Phase: N/A
• First received: March 13, 2012
• Last updated: November 10, 2012
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: March 2012
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: August 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Thailand	Queen Sirikit Heart Cenrter	Khon Kaen
Thailand	Queen Sirikit Heart Center	Khon Kaen

Sponsors (2)

Lead Sponsor	Collaborator
Thepakorn Sathitkarnmanee	Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No