Clinical Trials Directory

Trials / Completed

CompletedNCT03068689

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
University Hospital, Basel, Switzerland · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURERIPCRIPC 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.
OTHERPlaceboPlacebo

Timeline

Start date
2017-12-01
Primary completion
2023-05-03
Completion
2023-05-03
First posted
2017-03-03
Last updated
2025-02-11

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03068689. Inclusion in this directory is not an endorsement.