NCT01559870

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

3 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

August 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 14, 2012

Status Verified

March 1, 2012

Enrollment Period

7 months

First QC Date

March 13, 2012

Last Update Submit

November 10, 2012

Conditions

Heart; Dysfunction Postoperative, Cardiac SurgeryCytokine Release Syndrome

Keywords

cardiac surgerycytokineclinical scoring systemrisk factor

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

patients with elective cardiac surgery

adult patients who had undergone elective cardiac surgery with CPB

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients who had undergone elective cardiac surgery with CPB

You may qualify if:

  • adult patients who had undergone elective cardiac surgery with CPB

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Queen Sirikit Heart Cenrter

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Queen Sirikit Heart Center

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Queen Sirikit Heart Center

Khon Kaen, 40002, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood taken from arterial line

MeSH Terms

Conditions

Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 13, 2012

First Posted

March 21, 2012

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

August 1, 2012

Last Updated

November 14, 2012

Record last verified: 2012-03

Locations

TH(3)