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"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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (RIPC) | Experimental | RIPC treatment prior to partial nephrectomy. |
|
| Placebo Control | Placebo Comparator | Placebo prior to partial nephrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIPC | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker reduction | 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. | Baseline, 5 days and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute renal failure | 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) | Baseline, 5 days, 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Ebbing, MD, Dr. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel, Clinic of Urology | Basel | 4056 | Switzerland |
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| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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|
| Placebo | Other | Placebo |
|
| Chronic renal failure | 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). | Baseline, 3 Months |
| Tubular damage in BOLD MRT | Δ R2*-values in BOLD magnetic resonance tomography (MRT) will be compared between both groups. | Baseline, day 2 |
| D013568 | Pathological Conditions, Signs and Symptoms |