Study of the Clinical Scoring System and Cytokines for Pr... | NCT01353157

Studies
Study of the Clinical Scoring System and Cytokines for Prediction of Inflammatory Response in Major Surgery

NCT01353157

Sponsor

Khon Kaen University

Status

Completed

Last Update Posted

May 12, 2011Estimated

Enrollment

20Actual

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

Feb 2010

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

Mar 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

May 4, 2011

First Submission Date that Met QC Criteria

May 11, 2011

First Posted Date

May 12, 2011Estimated

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

May 11, 2011

Last Update Posted Date

May 12, 2011Estimated

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

Cardiac surgery with cardiopulmonary bypass (CPB) and hepatic surgery are major operations, associated with a systemic inflammatory response syndrome. The aim of this study is to assess the effectiveness of clinical scoring systems and inflammatory cytokine levels for predicting systemic inflammation. This correlation might identify peri-operative clinical outcomes, then forecast further systemic inflammation in cardiac and hepatic surgical patients.

Detailed Description

Systemic inflammatory response syndrome (SIRS) is commonly found in most major surgery. Early detection of SIRS will lead to early treatment. Serum cytokines levels are reliable markers for SIRS detection but with high cost and inconvenience. Clinical Scoring Systems are commonly used for assessment of patients with SIRS. If they have good correlation with cytokine levels, they might be used to predict peri-operative clinical outcomes.

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

20Actual

Label	Type	Description	Intervention Names
patients with elective cardiac surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation of clinical scoring systems and inflammatory cytokine levels	Blood samples were collected sequentially at 0, 0.5, 4, 12, and 24 h after CPB for cytokines [Interleukin (IL)-6, IL-8, and IL-10] investigation and leukocyte counts. Clinical scoring systems [Acute Physiology and Chronic Health Evaluation (APACHE) II, Sequential Organ Failure Assessment (SOFA) and Multi-Organ Dysfunction (MOD)] were calculated and recorded at each time point. Correlations were assessed.	24 h 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

Not provided

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

Name	Affiliation	Role
Sirirat Tribuddharat, MD	Khon Kaen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Sirikit Heart Center of the Northeast, Khon Kaen University		Khon Kaen	Changwat Khon Kaen	40002	Thailand

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