Clinical trial NCT03068689: Remote Ischaemic PreConditioning (RIPC) in Partial Nephrectomy for the Prevention of Ischemia/Reperfusion Injury
Official title: Remote Ischaemic PreConditioning (RIPC) in Partial Nephrectomy for the Prevention of Ischemia/Reperfusion Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reperfusion Injury
Keywords: Partial nephrectomy, RIPC, Reperfusion Injury
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Biomarker reduction
timeFrame: Baseline, 5 days and 3 months
Secondary outcomes:
measure: Acute renal failure
timeFrame: Baseline, 5 days, 3 Months
measure: Chronic renal failure
timeFrame: Baseline, 3 Months
measure: Tubular damage in BOLD MRT
timeFrame: Baseline, day 2
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Clinic of Urology
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Jan Ebbing, MD, Dr.
role: PRINCIPAL_INVESTIGATOR
References: