OPS-2013:5-35 (Operations on valves and septa of the heart and vessels near the heart, 5-361 (creation of an aortocoronary bypass) N17.99
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with coronary heart disease and/ or heart valve disease and an increased risk for the development of a postoperative AKI (Cleveland score = 6) who have to undergo cardiac surgery with the use of the heart- lung machine. 2. Written informed consent of patient.
Exclusion criteria
Exclusion criteria: Acute myocardial infarction = 7 days before surgery age < 18 Off pump heart surgery Pre- existing AKI chronic kidney disease with eGFR < 30 ml/min Prior kidney transplant within the last 12 months Peripheral vascular disease affecting the upper limbs Pregnancy Hepatorenal syndrome Drug therapy with sulphonamide (incl. Thiazides) within the last 7 days Participation in another intervention study in the last 30 days Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute changes in Biomarker levels (urinary TIMP*IGFBP7 postoperative (after RIPC/sham-RIPC intervention) minus preoperative (before RIPC/sham-RIPC intervention)). | — |
Secondary
| Measure | Time frame |
|---|---|
| - AKI within 72 h after cardiac surgery -MAKE on day 30 and day 90 (make = combined target criterion consisting of death, need for dialysis and persistent renal dysfunction (defined as increase in serum creatinins = 0.5 mg/dl via baseline) -MAKEmod on Day 30 and day 90 (MAKEmod = modified combined target criterion from death, need for dialysis and drop of eGFR by = 25% to baseline) -Renal recovery after acute kidney injury on day 30 and 90 (defined as ? serum creatinine < 0.5 mg/dl compared to baseline and a drop in eGFR < 25% or < 50%). -need for dialysis on Day 30 and day 90 -Mortality on day 30 and day 90 | — |
Countries
Germany
Contacts
Klinik für Anästhesiologie, operative intensivmedizin und Schmerztherapie