Reperfusion Injury
Conditions
Keywords
Partial nephrectomy, RIPC, Reperfusion Injury
Brief summary
Remote Ischaemic PreConditioning (RIPC) is performed prior to partial nephrectomy. Postoperative calprotectin dynamics and Blood Oxygen-Level-Dependent (BOLD) MRI are used to to demonstrate the potential renoprotective effect of RIPC
Detailed description
Partial nephrectomy represents the gold standard in organ sparing kidney surgery. Cold ischaemia prevents major bleeding but can yet be associated with impaired kidney function due to reperfusion injury to the tubuli. Patients undergoing partial nephrectomy (any surgical technique, open, retroperitoneoscopic, transperitoneal, Da Vinci assisted) will be treated with Remote Ischaemic PreConditioning (RIPC). RIPC is delivered with a standard blood pressure cuff placed on the upper arm and another standard blood pressure cuff placed on the upper thigh. The cuffs are then simultaneously inflated to 200 mm HG and left inflated for 5 minutes, then deflated to 0 mmHG and left uninflated for 5 minutes. This cycle is repeated twice, so that the RIPC protocol takes 20 minutes in total. If the systolic blood pressure is \> 185mm HG the cuffs are inflated to 15 mmHG above that level. Several studies already demonstrated the reno- and cardioprotective potential of Remote Ischaemic PreConditioning (RIPC). It was shown that urinary calprotectin can be used to monitor tubular damage after nephron sparing surgery. Postoperative calprotectin dynamics will be monitored in order to demonstrate the potential renoprotective effect of RIPC. Additionally a BOLD MRI will be performed to to visualize ischemia/reperfusion injury.
Interventions
PROCEDURERIPC
RIPC is delivered with a standard blood pressure cuff placed on the upper arm and another standard blood pressure cuff placed on the upper thigh. The cuffs are then simultaneously inflated to 200 mm HG and left inflated for 5 minutes, then deflated to 0 mmHG and left uninflated for 5 minutes. This cycle is repeated twice, so that the RIPC protocol takes 20 minutes in total. If the systolic blood pressure is \> 185mm HG the cuffs are inflated to 15 mmHG above that level.
OTHERPlacebo
Placebo
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed Consent as documented by signature (Appendix Informed Consent Form) * Kidney tumor (any entity, benign, malign) * Partial nephrectomy (any surgical technique, open, retroperitoneoscopic, transperitoneal, Da Vinci assisted) * 18 years of age * Sufficient perfusion of all 4 extremities * palpable distal pulses: A. radialis and A. dorsalis pedis or A.tibialis post.
Exclusion criteria
* Women who are pregnant * Significant peripheral arterial disease affecting upper and/or lower limbs or history of * Significant renal disease (GFR \<15 ml/min/1.73m2) or undergoing haemodialysis * Concomitant therapy with glibenclamide or nicorandil (due to potential inference with RIPC) * Urothelial cancer * Acute Urinary tract infection * international normalized ratio (INR) \>2 (haematoma risk at cuff site)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker reduction | Baseline, 5 days and 3 months | The study seeks primarily to determine the reduction of the biomarker concentration (Calprotectin and NGAL) in urine. Change in biomarkers will be measured at baseline, during 5 days after surgery and at timepoint month 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic renal failure | Baseline, 3 Months | Number of patients with chronic renal failure will be compared between both groups. Chronic renal failure will be assessed in at baseline until timepoint month 3 (chronic kidney failure). |
| Tubular damage in BOLD MRT | Baseline, day 2 | Δ R2\*-values in BOLD magnetic resonance tomography (MRT) will be compared between both groups. |
| Acute renal failure | Baseline, 5 days, 3 Months | The secondary objective is to demonstrate the effect/reduction acute renal failure after RIPC as compared to the control group. Number of patients with acute renal failure will be compared between both groups. Acute renal failure will be assessed in the days after surgery (acute kidney failure) |
Countries
Switzerland
Outcome results
None listed