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Clinical Trials/NCT02054871
NCT02054871
Unknown
Not Applicable

Randomised Controlled Trial to Evaluate the Reno-protective Benefits of Remote Ischaemic Preconditioning in Patients Undergoing Infrainguinal Peripheral Angioplasty

Mid Western Regional Hospital, Ireland1 site in 1 country40 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Vascular Disease
Sponsor
Mid Western Regional Hospital, Ireland
Enrollment
40
Locations
1
Primary Endpoint
Renal impairment
Last Updated
12 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
August 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Mid Western Regional Hospital, Ireland
Responsible Party
Principal Investigator
Principal Investigator

Professor Stewart Walsh

Consultant Vascular Surgeon

Mid Western Regional Hospital, Ireland

Eligibility 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)

Outcomes

Primary Outcomes

Renal impairment

Time Frame: 72 hours post procedural

Serial assessment of renal biomarkers in serum and urine in 72 hour period post procedure

Secondary Outcomes

  • Anti-inflammatory effect of RIPC(3-6 months post recruitment)

Study Sites (1)

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