Peri-operative Prediction of Prolonged Stay in the Cardia... | NCT01559870

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

NCT01559870

Sponsor

Thepakorn Sathitkarnmanee

Status

Completed

Last Update Posted

Nov 14, 2012Estimated

Enrollment

164Actual

Phase

Not provided

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery
Cytokine Release Syndrome

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Mar 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Mar 13, 2012

First Submission Date that Met QC Criteria

Mar 20, 2012

First Posted Date

Mar 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2012

Last Update Posted Date

Nov 14, 2012Estimated

Name	Class
Khon Kaen University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

164Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with elective cardiac surgery		adult patients who had undergone elective cardiac surgery with CPB

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

adult patients who had undergone elective cardiac surgery with CPB

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Sirikit Heart Cenrter		Khon Kaen	Changwat Khon Kaen	40002	Thailand
Queen Sirikit Heart Center

Condition Browse Module

MeSH Terms

ID	Term
D000080424	Cytokine Release Syndrome

Ancestor Terms

ID	Term
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided