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INFLAMMATORY INJURY of the LUNG after CARDIAC SURGERY


- candidate number22232
- NTR NumberNTR5314
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mei-2015
- Secondary IDsp11-117 MEC LUMC leiden
- Public TitleINFLAMMATORY INJURY of the LUNG after CARDIAC SURGERY
- Scientific TitleINFLAMMATORY INJURY of the LUNG after CARDIAC SURGERY
- ACRONYMINFLAME
- hypothesisInflammatory injury of the lung after cardiac surgery in heart failure versus non-heart failure patients; An observational study of clinical variables, genetic association, and etiologic and prognostic aspects of inflammatory markers in serum and endobronchial samples in patients with pulmonary injury after cardiac surgery.
- Healt Condition(s) or Problem(s) studiedAcute Respiratory Distress Syndrome, Cardiac surgery, Inflammation
- Inclusion criteriaAll adult patients, that are scheduled for all types of elective cardiac surgery, with or without CPB. For the purpose of the study low risk cardiac surgery is defined as CABG with single valve reconstruction or replacement. Complex cardiac surgery is defined as: multiple valves reconstruction or replacement, and/or heart failure surgery (DOR, corcap)
- Exclusion criteriaInability to sign informed consent, less than 18 years old, emergency operations
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2011
- planned closingdate31-dec-2017
- Target number of participants160
- Interventionsnone
- Primary outcomeLength of ICU-stay, length of hospital-stay, ICU-mortality, 30-day mortality
- Secondary outcome1. Prognostic: occurrence of ALI and ARDS, duration of mechanical ventilation, need for renal replacement therapy
2. Etiologic: levels and time course of markers of inflammation and ischemia-reperfusion in relation to the clinical course (such as AlI and ARDS, duration of mechanical ventilation, need for renal replacement therapy, ICU-stay, hospital-stay, ICU-mortality, 30-day mortality) particular in patients following complex heart surgery as opposed to low risk surgery
3. Methodologic: Investigate the value of collecting minimal invasive endobronchial samples in cardiac surgery patients.
- Timepointsfollow up period 30 days
- Trial web sitenone
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESM.S. Arbous Judith van Paassen
- CONTACT for SCIENTIFIC QUERIESM.S. Arbous Judith van Paassen
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Fund = Initiator = Sponsor
- Publicationsnone
- Brief summaryAfter cardiac surgery an inflammatory response develops, due to cardiopulmonary bypass (CPB) and ischemia-reperfusion injury. This response is more pronounced in patients with pre-existent heart failure. Due to this response, injury of several organs develops, leading to a complicated course and a prolonged stay at the intensive care. Particularly, when injury of the lung develops, ventilation time increases, associated with a raise of mortality up to 25 % in certain patient-groups. The causes of this lung injury are multifactorial: partly secondary to filtration of inflammatory factors due to ischemia-reperfusion of other organs, partly secondary to absence of ventilation during CPB and finally secondary to ischemia reperfusion of the lung since solely arterial bronchialis perfusion is insufficient to provide the complete metabolic needs of the lung. But up to now full details on the pathogenesis of lung injury post CPB are unknown.

Study objective.
It is our aim to predict the clinical course (in terms of occurrence of ALI and ARDS, duration of mechanical ventilation, need for renal replacement therapy, length of ICU-stay, length of hospital-stay, ICU-mortality, 30-day mortality) in patients after cardiac surgery. In addition to demographic and clinical prognostic parameters, the focus will be on the additional prognostic ability of markers of inflammation and ischemia reperfusion injury, of genetic predisposition and of measures of gene-expression to predict the clinical course following cardiac surgery. Furthermore, in light of the already available knowledge on inflammatory and ischemia-reperfusion markers, we aim to explain the clinical course of patients after complex and low risk cardiac surgery in relation to the inflammatory and ischemia-reperfusion response, particular occurring in the lung.

Endpoints of the Study.
Primary endpoints: Length of ICU-stay, length of hospital-stay, ICU-mortality, 30-day mortality Secondary endpoints: 1. Prognostic: occurrence of ALI and ARDS, duration of mechanical ventilation, need for renal replacement therapy
2. Etiologic: levels and time course of markers of inflammation and ischemia-reperfusion in relation to the clinical course (such as ALI and ARDS, duration of mechanical ventilation, need for renal replacement therapy, ICU-stay, hospital-stay, ICU-mortality, 30-day mortality) particular in patients following complex heart surgery as opposed to low risk surgery
3. Methodologic: Investigate the value of collecting minimal invasive endobronchial samples in cardiac surgery bypass patients.

- Main changes (audit trail)
- RECORD26-mei-2015 - 24-aug-2015


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