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RCT to Evaluate the Renal Protective Effects of Remote Ischaemic Preconditioning in Peripheral Angioplasty

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ClinicalTrials.gov Identifier: NCT02054871
Recruitment Status : Unknown
Verified February 2014 by Professor Stewart Walsh, Mid Western Regional Hospital, Ireland.
Recruitment status was:  Recruiting
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Professor Stewart Walsh, Mid Western Regional Hospital, Ireland

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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Procedure: RIPC Not Applicable

Detailed Description:

Ischaemic preconditioning is an endogenous mammalian mechanism whereby a brief period of ischaemia and reperfusion confers resistance to subsequent prolonged ischaemic insults. First observed in the canine heart, subsequent investigators noted that brief ischaemia in remote organs e.g. skeletal muscle, induced protection in key central organs e.g. the heart. This remote ischaemic preconditioning (RIPC) does not require direct interference with the target organs' blood supply. It can be induced using blood pressure cuffs to produce brief episodes of upper limb ischaemia and reperfusion and confers protection upon numerous organs simultaneously. RIPC reduces myocardial injury following aortic aneurysm repair, cardiac surgery and angioplasty. It also reduces adverse ischaemic events up to six months following percutaneous coronary intervention, implying some medium-term effect.

To date ischaemic conditioning has been applied primarily to the heart however animal studies have shown pre conditioning to offer renal protection.

Fikret et al in 2012 in the Renal Protection Trial demonstrated a protective benefit with RIPC from the development of CIN in high risk patients undergoing elective coronary angiography.Whittaker and Przyklenk in 2011 explored this concept retrospectively using data from patients who had undergone emergency angioplasty for ST elevation myocardial infarction. The original trial was a RCT which examined the protective effect of postconditioning on myocardial ischemia. The authors retrospectively examined if study patients treated with multiple coronary balloon inflations had better renal function than patients not exposed to this remote conditioning. They concluded that patients in the conditioning group received 25% more contrast volume than the control group and showed no decline in renal function as demonstrated by examination of glomular filtration rate at day 3 post procedure in comparison to the control group which saw a significant decline in renal function. The need for contrast-based procedures is rising, with increasing numbers of patients undergoing endovascular procedures, as is the incidence of postcontrast renal failure, which has a reported mortality of 34%. The potential use of RIPC therefore to reduce the risk of kidney damage needs further investigation in a prospective study and the PAD patient group who are routinely exposed to contrast administration in angiography are an ideal study group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial to Evaluate the Reno-protective Benefits of Remote Ischaemic Preconditioning in Patients Undergoing Infrainguinal Peripheral Angioplasty
Study Start Date : September 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: EGFR 30-60

Experimental: 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.

Procedure: RIPC
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.

Experimental: EGFR 60-90
Experimental: 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.
Procedure: RIPC
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.

No Intervention: EGRF 30-60

No 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.

No Intervention: EGRF 60-90
No 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.



Primary Outcome Measures :
  1. Renal impairment [ Time Frame: 72 hours post procedural ]
    Serial assessment of renal biomarkers in serum and urine in 72 hour period post procedure


Secondary Outcome Measures :
  1. Anti-inflammatory effect of RIPC [ Time Frame: 3-6 months post recruitment ]
    Assessment of additional postulated benefits of anti-inflammatory effects with RIPC in terms of decreased restenosis rates and lower inflammatory markers



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054871


Contacts
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Contact: Kamsila Pillay, MbCHB kamsilakp@yahoo.co.uk

Locations
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Ireland
HSE Mid Western Regional Hospital Recruiting
Limerick, Ireland
Contact: Kamsila Pillay       kamsilakp@yahoo.co.uk   
Sub-Investigator: Kamsila Pillay         
Sponsors and Collaborators
Mid Western Regional Hospital, Ireland
Investigators
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Principal Investigator: Stewart Walsh, MCh FRCS University of Limerick

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Responsible Party: Professor Stewart Walsh, Consultant Vascular Surgeon, Mid Western Regional Hospital, Ireland
ClinicalTrials.gov Identifier: NCT02054871    
Other Study ID Numbers: MWRH09644
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014
Keywords provided by Professor Stewart Walsh, Mid Western Regional Hospital, Ireland:
Peripheral Angioplasty
Remote Ischaemic Preconditioning
Contrast Induced Nephropathy
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases