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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01559870
First Posted: March 21, 2012
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Khon Kaen University
Information provided by (Responsible Party):
Thepakorn Sathitkarnmanee, Khon Kaen University
  Purpose
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

Condition
Heart; Dysfunction Postoperative, Cardiac Surgery Cytokine Release Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Peri-operative Prediction of Prolonged Stay in the Cardiac Intensive Care Unit for Adult Cardiac Surgery With Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Thepakorn Sathitkarnmanee, Khon Kaen University:

Primary Outcome Measures:
  • Adjusted odds ratio of peri-operative clinical risk factors in prolonged CICU patients [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
whole blood taken from arterial line

Enrollment: 164
Study Start Date: August 2011
Study Completion Date: August 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with elective cardiac surgery
adult patients who had undergone elective cardiac surgery with CPB

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patients who had undergone elective cardiac surgery with CPB
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559870


Locations
Thailand
Queen Sirikit Heart Cenrter
Khon Kaen, Thailand, 40002
Queen Sirikit Heart Center
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Thepakorn Sathitkarnmanee
Khon Kaen University
  More Information

Responsible Party: Thepakorn Sathitkarnmanee, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01559870     History of Changes
Other Study ID Numbers: HE541122
First Submitted: March 13, 2012
First Posted: March 21, 2012
Last Update Posted: November 14, 2012
Last Verified: March 2012

Keywords provided by Thepakorn Sathitkarnmanee, Khon Kaen University:
cardiac surgery
cytokine
clinical scoring system
risk factor