INFLACOR - Clinical and Genetic Predictors of Inflammation Related Complications After Heart Surgery (INFLACOR)
This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01020409
First received: November 24, 2009
Last updated: May 15, 2015
Last verified: May 2015
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| First Received Date ICMJE | November 24, 2009 | |||||||||
| Last Updated Date | May 15, 2015 | |||||||||
| Start Date ICMJE | October 2009 | |||||||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | |||||||||
| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | Complete list of historical versions of study NCT01020409 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures ICMJE |
all cause inhospital mortality [ Time Frame: from day 2 after operation ] [ Designated as safety issue: No ] | |||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Outcome Measures ICMJE | Not Provided | |||||||||
| Original Other Outcome Measures ICMJE | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | INFLACOR - Clinical and Genetic Predictors of Inflammation Related Complications After Heart Surgery | |||||||||
| Official Title ICMJE | INFLACOR - (INFLA-mmation, A-fter, C-ardiac, O-pe-R-ation) - Evaluation of Selected Genetic Polymorphisms, Inflammatory Mediators, 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. |
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| Study Type ICMJE | Observational | |||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples With DNA Description: plasma, serum, and blood morphologic elements after centrifugation frozen to -75C. |
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| 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 ICMJE | Systemic Inflammatory Response Syndrome | |||||||||
| Intervention ICMJE | Procedure: cardiac surgery with CPB use
heart or ascending aorta surgery performed with use of cardiopulmonary bypass with or without aortic cross clamping.
Other Names:
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| Study Group/Cohort (s) | CPB cardiac surgery
Adult patients, who signed the informed consent, intervention: first-time scheduled heart surgery with CPB use.
Intervention: Procedure: cardiac surgery with CPB use |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Enrollment ICMJE | 525 | |||||||||
| Completion Date | November 2012 | |||||||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | |||||||||
| Ages | 18 Years and older (Adult, Senior) | |||||||||
| Accepts Healthy Volunteers | Yes | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Poland | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01020409 | |||||||||
| Other Study ID Numbers ICMJE | N N403 1815 34, MUG grant G-35 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| Plan to Share Data | Not Provided | |||||||||
| IPD Description | Not Provided | |||||||||
| Responsible Party | Maciej M. Kowalik, Medical University of Gdansk | |||||||||
| Study Sponsor ICMJE | Medical University of Gdansk | |||||||||
| Collaborators ICMJE | Ministry of Science and Higher Education, Poland | |||||||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Gdansk | |||||||||
| Verification Date | May 2015 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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