No registrations found.
ID
Source
Brief title
Health condition
ARDS, Lung injury, Cardiac Surgery, CPB, Ivflammatory response
Sponsors and support
Intervention
Outcome measures
Primary outcome
Length of ICU-stay, length of hospital-stay, ICU-mortality, 30-day mortality
Secondary outcome
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 patients.
Background summary
After 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.
Study objective
Inflammatory 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.
Study design
follow up period 30 days
Intervention
none
Judith van Paassen
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
Telephone: 071-5262782
Email: j.van_paassen@lumc.nl
Judith van Paassen
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
Telephone: 071-5262782
Email: j.van_paassen@lumc.nl
Inclusion criteria
All 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 criteria
Inability to sign informed consent, less than 18 years old, emergency operations
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5174 |
| NTR-old | NTR5314 |
| Other | MEC LUMC leiden : p11-117 |