INFLACOR - Clinical and Genetic Predictors of Inflammation Related Complications After Heart Surgery (INFLACOR)
|
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. |
| ClinicalTrials.gov Identifier: NCT01020409 |
|
Recruitment Status
:
Completed
First Posted
: November 25, 2009
Last Update Posted
: November 15, 2016
|
Sponsor:
Medical University of Gdansk
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by (Responsible Party):
Maciej M. Kowalik, Medical University of Gdansk
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | November 24, 2009 | |||||||||
| First Posted Date | November 25, 2009 | |||||||||
| Last Update Posted Date | November 15, 2016 | |||||||||
| Study Start Date | October 2009 | |||||||||
| Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
Clinical phenotypes of inflammatory response: SIRS, acute lung injury/acute respiratory distress syndrome, acute kidney injury, atrial fibrillation, postoperative psychosis, perioperative myocardial infarct/injury, sepsis. [ Time Frame: between day 2 after operation and hospital discharge ] | |||||||||
| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | Complete list of historical versions of study NCT01020409 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures |
all cause inhospital mortality [ Time Frame: from day 2 after operation ] | |||||||||
| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Outcome Measures | Not Provided | |||||||||
| Original Other Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | INFLACOR - Clinical and Genetic Predictors of Inflammation Related Complications After Heart Surgery | |||||||||
| Official Title | INFLACOR (INFLA-mmation A-fter C-ardiac O-pe-R-ation) - Use of Selected Genetic Variants, Cytokines, and Physiologic Parameters in the Prognosis of Postoperative Complications in Patients Undergoing Cardiopulmonary Bypass Cardiac Surgery | |||||||||
| Brief Summary | The aim of the study is to evaluate a clinically and economically most effective diagnostic algorithm for prediction of inflammatory response related complications in patients undergoing heart surgery with use of cardiopulmonary bypass. | |||||||||
| Detailed Description | Identified so far predictors of mortality and/or morbidity in patients who undergo heart surgery with cardiopulmonary bypass (CPB), used in previous risk prediction models (EUROSCORE, CABDEAL, Cleveland), will be compared with new candidate variables:
against their predictive capability of selected clinical phenotypes of inflammatory response occuring after surgery, beginning from day 2. after surgery. |
|||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
|||||||||
| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples With DNA Description: plasma, serum, and blood morphologic elements after centrifugation frozen to -75C. |
|||||||||
| Sampling Method | Probability Sample | |||||||||
| Study Population | Adults (at least age 18), who signed informed consent, scheduled for elective cardiac surgery with use of cardiopulmonary bypass. | |||||||||
| Condition | Systemic Inflammatory Response Syndrome | |||||||||
| Intervention | Procedure: cardiac surgery with CPB use
cardiac surgery with CPB use or ascending aorta surgery performed with use of cardiopulmonary bypass with or without aortic cross clamping.
Other Names:
|
|||||||||
| Study Groups/Cohorts | cardiac surgery with CPB use
Adult patients, who signed the informed consent, intervention: first-time scheduled heart surgery with CPB use.
Intervention: Procedure: cardiac surgery with CPB use |
|||||||||
| Publications * |
|
|||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
525 | |||||||||
| Original Estimated Enrollment |
500 | |||||||||
| Actual Study Completion Date | November 2012 | |||||||||
| Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||
| Sex/Gender |
|
|||||||||
| Ages | 18 Years and older (Adult, Senior) | |||||||||
| Accepts Healthy Volunteers | Yes | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Poland | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT01020409 | |||||||||
| Other Study ID Numbers | N N403 1815 34 MUG grant G-35 ( Other Identifier: Medical University of Gdańsk ) |
|||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement |
|
|||||||||
| Responsible Party | Maciej M. Kowalik, Medical University of Gdansk | |||||||||
| Study Sponsor | Medical University of Gdansk | |||||||||
| Collaborators | Ministry of Science and Higher Education, Poland | |||||||||
| Investigators |
|
|||||||||
| PRS Account | Medical University of Gdansk | |||||||||
| Verification Date | November 2016 | |||||||||