circulation Shock circulation Shock
Conditions
Interventions
Use of mitoPO2 to guide therapy for shock during and 24 hours after cardiac surgery in the intervention group compared to use of standard monitoring to guide therapy in the control group
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: High risk patients undergoing elective cardiac surgery
Exclusion criteria
Exclusion criteria: Intollerance to ALA plaster components;Mitochondrial disease (porphyria);Pregnancy or lactation;Upper arm skin lesions that might interfere with measurements, including extensive tattoos;Heart transplantation;Emergency surgery;Need for an assist device (a.o. ECMO, intra-aortic balloon pump, or impella) either directly prior or immediately after surgery;Deep hypothermic circulatory arrest;Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of AKI in the first 48 hours after cardiac surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sequential Organ Failure Assessment (SOFA) score and APACHE IV score of the first 24 hours of ICU stay;Daily and total averaged integral of volume of fluid therapy and of vaso-active medication (noradrenaline, milrinone, dobutamine, vasopressin, and methylene-blue are calculated separately) during monitoring period, for up to 24 hours after start of surgery;Adherence to suggested therapy, recorded after each mitoPO2 read-out (intervention arm only);Rethoracotomy;All-cause mortality at 28 days;Area under the curve of CK-MB and creatinine, for up to 48 hours after ICU admission;ICU and hospital length of stay. | — |
Countries
Netherlands
Contacts
Public ContactT. Teeuwen
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed