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

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University Hospital Basel

Status

Enrolling

Conditions

Reperfusion Injury

Treatments

Procedure: RIPC
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03068689
RIPC

Details and patient eligibility

About

"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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups, including a placebo group

Intervention (RIPC)
Experimental group
Description:
RIPC treatment prior to partial nephrectomy.
Treatment:
Procedure: RIPC
Placebo Control
Placebo Comparator group
Description:
Placebo prior to partial nephrectomy.
Treatment:
Other: Placebo

Trial contacts and locations

0

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Central trial contact

Jan Ebbing, MD, Dr.

Data sourced from clinicaltrials.gov

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