Primary Objective: the relation between the occurrence of CSA-AKI and the duration of peri-operative low mitoPO2 measurements (<20 mmHg). Secondary Objective: The relation between the occurrence of delirium and the duration of…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Health condition
Coronary artery bypass (CABG) requiring cardiopulmonary bypass and who have a high risk of developing CSA-AKI, according to the AKICS prediction score
Research involving
Sponsors and support
Intervention
- Medical device
Outcome measures
Primary outcome
To study the relationship between the occurrence of acute kidney injury (AKI) and the duration of low mitoPO2 (<20 mmHg) during and up to 48 hours after cardiac surgery.
Secondary outcome
"To study the relationship between mitoPO2 and the standard hemodynamic monitoring parameters and other biomarkers measured during coronary artery bypass grafting (CABG)
To study the relationship between low mitoPO2 (<20 mmHg) during and up to 48 hours after cardiac surgery and the occurrence of delirium
To study the relationship between low mitoPO2 (<20 mmHg) during and up to 48 hours after cardiac surgery and the stay length in the intensive care unit (ICU), and the stay length in the hospital"
Background summary
Cardiac-surgery-associated acute kidney injury (CSA-AKI) is a common complication after cardiac surgery. CSA-AKI is independently associated with increased morbidity and mortality. Central in the development of CSA-AKI is the imbalance between oxygen supply and demand. This is often not recognized in time and can therefore not be prevented. Previous studies have shown the potential of monitoring cutaneous mitochondrial oxygen tension (mitoPO2) by the recently introduced Cellular Oxygen METabolism (COMET) (Photonics Healthcare B.V., Utrecht).This study will investigate whether there is a correlation between perioperative duration of low mitochondrial oxygen tension (<20 mmHg) and CSA-AKI. Since delirium after cardiac surgery may also be caused by an oxygen deficiency in the tissue, we will further investigate the relationship between perioperative duration of low mitochondrial oxygen tension (<20 mmHg) and delirium.
Study objective
Primary Objective: the relation between the occurrence of CSA-AKI and the duration of peri-operative low mitoPO2 measurements (<20 mmHg).
Secondary Objective: The relation between the occurrence of delirium and the duration of perioperative low mitoPO2 measurements (<20 mmHg).
Study design
Single center observational study
Age
Inclusion criteria
- Age over 18 years - Acceptable proficiency of the Dutch language - Scheduled for Coronary Artery Bypass Grafting (CABG) surgery requiring cardiopulmonary bypass and who have a high risk of developing CSA-AKI, according to the AKICS prediction score (16)
Exclusion criteria
Presence of mitochondrial disease - Pregnancy/lactation - Patients with skin lesions on upper arm/shoulder which impede measurements - Porphyria - Known intolerance to components of the ALA plaster - Patients uncapable of providing informed consent, due to a mental condition interfering with the ability to understand the provided information
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9669 |
| CCMO | NL75770.078.20 |
| OMON | NL-OMON50959 |