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

Primary Purpose

Reperfusion Injury

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
RIPC
Placebo
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Reperfusion Injury focused on measuring Partial nephrectomy, RIPC, Reperfusion Injury

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • University Hospital Basel, Clinic of UrologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention (RIPC)

Placebo Control

Arm Description

RIPC treatment prior to partial nephrectomy.

Placebo prior to partial nephrectomy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 22, 2017
Last Updated
October 1, 2021
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03068689
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reperfusion Injury
Keywords
Partial nephrectomy, RIPC, Reperfusion Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (RIPC)
Arm Type
Experimental
Arm Description
RIPC treatment prior to partial nephrectomy.
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
Placebo prior to partial nephrectomy.
Intervention Type
Procedure
Intervention Name(s)
RIPC
Intervention Description
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 Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Biomarker reduction
Description
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.
Time Frame
Baseline, 5 days and 3 months
Secondary Outcome Measure Information:
Title
Acute renal failure
Description
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)
Time Frame
Baseline, 5 days, 3 Months
Title
Chronic renal failure
Description
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).
Time Frame
Baseline, 3 Months
Title
Tubular damage in BOLD MRT
Description
Δ R2*-values in BOLD magnetic resonance tomography (MRT) will be compared between both groups.
Time Frame
Baseline, day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Ebbing, MD, Dr.
Phone
+41(0)61 265 2525
Email
jan.ebbing@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Ebbing, MD, Dr.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel, Clinic of Urology
City
Basel
ZIP/Postal Code
4056
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Ebbing, MD
Phone
+41 61 2652525
Email
jan.ebbing@usb.ch
First Name & Middle Initial & Last Name & Degree
Christian Wetterauer, MD
Phone
+41 61 2652525
Email
christian.wetterauer@usb.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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

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