Effect of different anesthetic regimens on the renoprotective effects of remote ischemic preconditioning (RIPC) in high- risk patients undergoing cardiac surgery
- Conditions
- 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
- Registration Number
- DRKS00014989
- Lead Sponsor
- niversitätsklinikum MünsterKlinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 160
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.
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute changes in Biomarker levels (urinary TIMP*IGFBP7 postoperative (after RIPC/sham-RIPC intervention) minus preoperative (before RIPC/sham-RIPC intervention)).
- Secondary Outcome Measures
Name Time Method - AKI within 72 h after cardiac surgery <br>-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)<br>-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)<br>-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%).<br>-need for dialysis on Day 30 and day 90<br>-Mortality on day 30 and day 90