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

Not Applicable

Completed

• Conditions: Reperfusion Injury
• Interventions: Procedure: RIPC; Other: Placebo

• Registration Number: NCT03068689
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-03-03
• Study Start: 2017-12-01
• Primary Completion: 2023-05-03
• Study Completion: 2023-05-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (RIPC)	RIPC	RIPC treatment prior to partial nephrectomy.
Placebo Control	Placebo	Placebo prior to partial nephrectomy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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.

Trial Locations

Locations (1)

University Hospital Basel, Clinic of Urology; 🇨🇭 Basel, Switzerland