1. 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…
ID
Source
Brief title
Condition
- Heart failures
- Respiratory disorders NEC
- Cardiac therapeutic procedures
Synonym
Research involving
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
Rationale
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 ischemia-reperfusion injury of the
lung develops, ventilation time increases, associated with a raise of mortality
up to 25 % in certain patient-groups. But up to now only few details of
pathogenesis of this lung damage is known.
Study objective
1. 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.
2. To explain, in light of the already available knowledge on inflammatory and
ischemia-reperfusion markers, 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.
Study design
The study is designed as a single centre prospective observational cohort study
Study burden and risks
Patients will be treated according to routine care. Intravenous and arterial
access is available in all patients, since this is routine care in the thoracic
patient group. Furthermore endobronchial samples will be taken during routine
suctioning moments and only in intubated patients. Urine samples will be taken
fram the urinary catheter. The total amount of blood necessary will be utmost
210 cc. The extent of the burden will be very low and the risk associated with
paticipation is nihil.
albinusdreef 2 albinusdreef 2
Leiden 2333 ZA
NL
albinusdreef 2 albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Adult patients scheduled for cardiac surgery
Exclusion criteria
minor
ermergency surgery
not able to sign informed consent
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL36267.058.11 |