Remote Ischaemic PreConditioning (RIPC) in Partial Nephrectomy for the Prevention of Ischemia/Reperfusion Injury

University Hospital, Basel, Switzerland40 enrolled

Overview

"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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Reperfusion Injury

Interventions

RIPCPROCEDURE

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.

PlaceboOTHER

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

University Hospital Basel, Clinic of Urology

Basel, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 5 days and 3 months

Secondary Outcomes

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)

Time frame: Baseline, 5 days, 3 Months

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).

Time frame: Baseline, 3 Months

Tubular damage in BOLD MRT

Δ R2\*-values in BOLD magnetic resonance tomography (MRT) will be compared between both groups.

Time frame: Baseline, day 2

Data from ClinicalTrials.gov

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