RCT to Evaluate the Renal Protective Effects of Remote Ischaemic Preconditioning in Peripheral Angioplasty
Randomised Controlled Trial to Evaluate the Reno-protective Benefits of Remote Ischaemic Preconditioning in Patients Undergoing Infrainguinal Peripheral Angioplasty
1 other identifier
interventional
40
1 country
1
Brief Summary
This study aims to demonstrate if remote ischaemic preconditioning (RIPC) may confer renal protection in patients undergoing peripheral angioplasty. Patients will be randomised to receive RIPC and biomarkers for renal injury will be analysed post procedure to determine if any protective benefit was obtained.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 3, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFebruary 4, 2014
February 1, 2014
10 months
February 3, 2014
February 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Renal impairment
Serial assessment of renal biomarkers in serum and urine in 72 hour period post procedure
72 hours post procedural
Secondary Outcomes (1)
Anti-inflammatory effect of RIPC
3-6 months post recruitment
Study Arms (4)
EGFR 30-60
EXPERIMENTALExperimental: RIPC Remote preconditioning Calculated EGFR based on MDRD. Patients receive intravenous fluids preprocedure as additional renal protection. Preconditioning will be performed in the same manner as several previous trials. Immediately prior to angiography a CE-approved blood pressure cuff will be placed around one arm of the patient. It will then be inflated to a pressure of 200mmHg for 5 minutes. For patients with a systolic blood pressure \>185mmHg, the cuff will be inflated to at least 15mmHg above the patient's systolic blood pressure. The cuff will then be deflated and the arm allowed reperfuse for 5 minutes. This will be repeated so that each patient receives a total of 4 ischaemia-reperfusion cycles.
EGFR 60-90
EXPERIMENTALExperimental: RIPC Remote preconditioning. EGFR calculated using MDRD equation. Oral hydration pre-procedural as reno-protective measure. Preconditioning will be performed in the same manner as several previous trials. Immediately prior to angiography a CE-approved blood pressure cuff will be placed around one arm of the patient. It will then be inflated to a pressure of 200mmHg for 5 minutes. For patients with a systolic blood pressure \>185mmHg, the cuff will be inflated to at least 15mmHg above the patient's systolic blood pressure. The cuff will then be deflated and the arm allowed reperfuse for 5 minutes. This will be repeated so that each patient receives a total of 4 ischaemia-reperfusion cycles.
EGRF 30-60
NO INTERVENTIONNo Intervention: Remote preconditioning control Calculated EGFR based on MDRD. Patients receive intravenous fluids preprocedure as additional renal protection. Patients randomised to this group will receive routine care.
EGRF 60-90
NO INTERVENTIONNo Intervention: Remote preconditioning control EGFR calculated using MDRD equation. Oral hydration pre-procedural as reno-protective measure. Patients randomised to this group will receive routine care.
Interventions
A standard, CE-approved tourniquet cuff will be placed around one arm of the patient. It will then be inflated to a pressure of 200mmHg for 5 minutes. For patients with a systolic blood pressure \>185mmHg, the cuff will be inflated to at least 15mmHg above the patient's systolic blood pressure. The cuff will then be deflated and the arm allowed reperfuse for 5 minutes. This will be repeated so that each patient receives a total of 3 ischaemia-reperfusion cycles. Additional, blood and urine samples will be collected on Day 1, Day 2 and Day 3 post procedure.
Eligibility Criteria
You may qualify if:
- Elective intra-arterial, infrainguinal peripheral angiography/angioplasty
- Written informed consent
- Patients \>18yrs of age
- Patients with CKD (Stage2/3) as evidenced by eGFR \<90ml/min/1.73m2
You may not qualify if:
- Severe renal impairment eGFR \<30ml/min
- Evidence of acute renal failure or patients on dialysis
- History of previous CIN
- Contraindication to intravenous volume replacement therapy
- Pregnancy
- Patients on glibenclamide or nicorandil (these medications may interfere with RIPC)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HSE Mid Western Regional Hospital
Limerick, Limerick, Ireland
Related Publications (1)
Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.
PMID: 36645250DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stewart Walsh, MCh FRCS
University of Limerick
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Vascular Surgeon
Study Record Dates
First Submitted
February 3, 2014
First Posted
February 4, 2014
Study Start
September 1, 2013
Primary Completion
July 1, 2014
Study Completion
August 1, 2014
Last Updated
February 4, 2014
Record last verified: 2014-02