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Completed

NCT Number: NCT03068689

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

"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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel, Clinic of Urology

Basel, 4056, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Placebo

Other

Placebo

Primary outcomes

  1. Biomarker reduction

    Time frame: 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 outcomes

  1. Acute renal failure

    Time frame: 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)

  2. Chronic renal failure

    Time frame: 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).

  3. Tubular damage in BOLD MRT

    Time frame: Baseline, day 2

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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2017
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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