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

NCT03068689 | Completed

• 1 other identifier: RIPC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Reperfusion Injury

Keywords

Partial nephrectomy, RIPC, Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Acute renal failure

  Baseline, 5 days, 3 Months

• Chronic renal failure

  Baseline, 3 Months

• Tubular damage in BOLD MRT

  Baseline, day 2

Study Arms (2)

Intervention (RIPC)

EXPERIMENTAL

RIPC treatment prior to partial nephrectomy.

Procedure: RIPC

Placebo Control

PLACEBO COMPARATOR

Placebo prior to partial nephrectomy.

Other: Placebo

Interventions

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.

Intervention (RIPC)

Placebo OTHER

Placebo

Placebo Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years of age
• Sufficient perfusion of all 4 extremities
• palpable distal pulses: A. radialis and A. dorsalis pedis or A.tibialis post.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Clinic of Urology

Basel, 4056, Switzerland

Location

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Ebbing, MD, Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: December 1, 2017
• Primary Completion: May 3, 2023
• Study Completion: May 3, 2023
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)