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Completed

NCT Number: NCT01020409

INFLACOR - Clinical and Genetic Predictors of Inflammation Related Complications After Heart Surgery

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.

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Key information

Conditions

Systemic Inflammatory Response Syndrome Acute Kidney Injury Acute Lung Injury Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Infarction Infections Inflammation Ischemia Kidney Diseases Lung Diseases Lung Injury Male Urogenital Diseases Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Sepsis Shock Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Gdańsk, Academic Clinical Centre, Department of Cardiac Anaesthesiology

Gdansk, PL-80-211, Poland

About this study

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:

  • anamnestic: recent tooth extractions, chronic inflammatory diseases, specific drug use;
  • biochemical: C-reacting protein, interleukin-6, tumor necrosing factor alpha;
  • genetical: single nucleotide polymorphisms of 10 genes associated with inflammatory response; and
  • clinical from the 1. postoperative day: systemic inflammatory response syndrome, APACHE-III score;

against their predictive capability of selected clinical phenotypes of inflammatory response occuring after surgery, beginning from day 2. after surgery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults (age >=18)
  • given and signed informed consent
  • no previous cardiac surgery with opening the pericardium

Exclusion criteria

  • previous cardiac surgery with opening the pericardium
  • consent refused or not given

Treatment and study plan

cardiac surgery with CPB use

Procedure

cardiac surgery with CPB use or ascending aorta surgery performed with use of cardiopulmonary bypass with or without aortic cross clamping.

Other names: heart valve surgery, open heart surgery

Primary outcomes

  1. 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

Secondary outcomes

  1. all cause inhospital mortality

    Time frame: from day 2 after operation

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Collaborators

  • Ministry of Science and Higher Education, Poland

Registry information

Official study 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

Acronym: INFLACOR

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Nov 25, 2009
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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