Is a dropping mitoPO2 suggestive for the development of acute kidney injury and/or postoperative cognitive dysfunction after cardiac surgery?

Is a dropping mitoPO2 suggestive for the development of acute kidney injury and/or postoperative cognitive dysfunction after cardiac surgery? - MitoPO2 for postoperative CSA-AKI and POCD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50959

Enrollment

Registered

2021-02-18

Start date

2021-08-24

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery Associated Acute Kidney Injury kidney damage

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age over 18 years - Acceptable proficiency of the Dutch language - Scheduled for Coronary Artery Bypass Grafting requiring cardiopulmonary bypass and who have a high risk of developing AKI, according to the AKICS prediction score

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
- MitoPO2 (mmHg) measured semi-continuously peri-operatively and during 48 hours post-operatively using the automated setting of the COMET-device. - Serum creatinine and 24-hour urine output, measured daily to monitor the onset of CSA-AKI .	—

Secondary

Measure	Time frame
- CSA-AKI biomarkers, TIMP-2 and IGFBP-7, within 48 hours after ICU admission. These will be obtained during standard care sampling moments - Pre-operative baseline psychometric testing, using the MOCA, RVLT, TMT A en B, Grooved Pegboard Test, Hospital Anxiety and Depression Scale (HADS) - Post-operative psychometric testing, performed one week after cardiac surgery using the RVLT, TMT A and B, Grooved Pegboard Test and HADS - Post-operative psychometric testing performed three months after cardiac surgery using the RVLT, TMT A and B, Grooved Pegboard Test and HADS - Standard hemodynamic parameters and biomarkers are measured throughout the operation and the first 48 hours on the ICU: Blood pressure (mmHg), Peripheral perfusion index, Heart rate (bpm), Oxygen saturation (%), Core body temperature (degrees Celsius), End tidal carbon dioxide (kPa),Pump flow rate (L/min), Oxygen concentration of the fresh gas flow to the oxygenator of the pump (%), Haemoglobin (g/dl) and haematocrit (%) Oxygen delivery (DO2, ml/min) Temperature (degrees Celsius), Delta temperature (degrees Celsius), Capillary refill in seconds, Urine production and fluid balance (ml/24 hours), -The length of ICU stay (days), length of hospital stay (days) -Routine laboratory values (haemoglobin g/dl, serum creatinine (µmol/l), etc.), -The occurrence of delirium -Adverse events	—

Measure

Time frame

- CSA-AKI biomarkers, TIMP-2 and IGFBP-7, within 48 hours after ICU admission. These will be obtained during standard care sampling moments - Pre-operative baseline psychometric testing, using the MOCA, RVLT, TMT A en B, Grooved Pegboard Test, Hospital Anxiety and Depression Scale (HADS) - Post-operative psychometric testing, performed one week after cardiac surgery using the RVLT, TMT A and B, Grooved Pegboard Test and HADS - Post-operative psychometric testing performed three months after cardiac surgery using the RVLT, TMT A and B, Grooved Pegboard Test and HADS - Standard hemodynamic parameters and biomarkers are measured throughout the operation and the first 48 hours on the ICU: Blood pressure (mmHg), Peripheral perfusion index, Heart rate (bpm), Oxygen saturation (%), Core body temperature (degrees Celsius), End tidal carbon dioxide (kPa),Pump flow rate (L/min), Oxygen concentration of the fresh gas flow to the oxygenator of the pump (%), Haemoglobin (g/dl) and haematocrit (%) Oxygen delivery (DO2, ml/min) Temperature (degrees Celsius), Delta temperature (degrees Celsius), Capillary refill in seconds, Urine production and fluid balance (ml/24 hours), -The length of ICU stay (days), length of hospital stay (days) -Routine laboratory values (haemoglobin g/dl, serum creatinine (µmol/l), etc.), -The occurrence of delirium -Adverse events

—

Countries

Netherlands

Outcome results