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

Reperfusion Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03068689
• Other study ID #: RIPC
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: August 2023

Study information

• Verified date: October 2021
• Source: University Hospital, Basel, Switzerland
• Contact: Jan Ebbing, MD, Dr.
• Phone: +41(0)61 265 2525
• Email: jan.ebbing[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ischemia
• Reperfusion Injury
• Wounds and Injuries

Intervention

Procedure:
• 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.

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Clinic of Urology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	Tubular damage in BOLD MRT	? R2*-values in BOLD magnetic resonance tomography (MRT) will be compared between both groups.	Baseline, day 2