Preconditioning Shields Against Vascular Events in Surgery

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Abdominal aortic aneurysm
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Brief Title

Preconditioning Shields Against Vascular Events in Surgery

Official Title

Preconditioning Shields Against Vascular Events in Surgery: A Multi-centre Feasibility Trial of Preconditioning Against Adverse Events in Major Vascular Surgery (Preconditioning-SAVES)

Brief Summary

      Major vascular surgery involves operations to repair swollen blood vessels, clear debris from
      blocked arteries or bypass blocked blood vessels. Patients with these problems are a
      high-risk surgical group as they have generalized blood vessel disease. These puts them at
      risk of major complications around the time of surgery such as heart attacks , strokes and
      death. The mortality following repair of a swollen main artery in the abdomen is about 1 in
      20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple
      and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote
      ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to
      muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a
      further five minutes. This cycle is repeated three more times. The blood supply is
      interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated
      brief interruption of the muscular blood supply sends signals to critical organs such as the
      brain and heart, which are rendered temporarily resistant to damage from reduced blood
      supply. Several small randomized clinical trials in patients undergoing different types of
      major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial
      aims to determine whether RIPC can reduce complications in routine practice.

Detailed Description

      The demand for major vascular surgery is increasing [1]. Patients requiring procedures such
      as aortic aneurysm repair, carotid endarterectomy, lower limb surgical re-vascularisation and
      major lower limb amputation for end-stage vascular disease constitute a high-risk surgical
      cohort. Peri-operative complications such as myocardial infarction, cerebrovascular accident,
      renal failure and death are common [2,3]. Multiple potential mechanisms may result in these
      complications. For example, myocardial injury may result from systemic hypotension leading to
      reduced flow across a tight coronary artery stenosis or, alternatively, it may arise due to
      acute occlusion when an unstable plaque ruptures. Most strategies aimed at peri-operative
      risk reduction target a single potential mechanism. For example, beta-blockade may prevent
      myocardial injury due to overwork, but cannot prevent acute coronary occlusion. There is a
      requirement for a simple, effective intervention that protects tissues against injury via
      multiple different mechanisms. Remote ischemic preconditioning (RIPC) may be suitable.

      Ischemic preconditioning is a phenomenon whereby a brief period of non-lethal ischemia in a
      tissue renders it resistant to the effects of a subsequent much longer ischaemic insult. It
      was first described in the canine heart [4]. Subsequent clinical trials showed that ischemic
      preconditioning reduced heart muscle damage following coronary artery bypass grafting [5] and
      liver dysfunction following hepatic resection [6]. Following cardiac surgery, it is
      associated with a reduction in critical care stay, arrhythmias and inotrope use [7]. However,
      ischemic preconditioning requires direct interference with the target tissues' blood supply,
      limiting its clinical utility. Further experimental work suggested that brief ischemia in one
      tissue, such as the kidneys, could confer protection on distant organs such as the heart [8].
      A similar effect was observed after transient skeletal muscle ischemia [9-11]. This effect is
      referred to as 'preconditioning at a distance' or 'remote ischemic preconditioning' (RIPC).

Study Type

Interventional

Primary Outcome

Serum troponin levels

Secondary Outcome

 Composite Major Adverse Clinical Events

Condition

Abdominal Aortic Aneurysm

Intervention

Remote ischaemic preconditioning

Study Arms / Comparison Groups

 Remote ischaemic preconditioning
Description:  Remote ischaemic preconditioning will be performed in the same manner as several previous trials. Immediately after induction of anaesthesia, a standard, 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. In all other respects, the procedure and peri-operative care will follow the routine practices of the surgeons and anaesthetists involved.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

400

Start Date

April 2014

Completion Date

August 2017

Primary Completion Date

April 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Age greater than 18 years

          -  Patient willing to give full informed consent for participation

          -  Patients undergoing elective carotid endarterectomy or

          -  Patients undergoing open abdominal aortic aneurysm repair or

          -  Patients undergoing endovascular abdominal aneurysm repair or

          -  Patients undergoing surgical lower limb revascularisation (suprainguinal or
             infrainguinal)

        Exclusion Criteria:

          -  Pregnancy

          -  Significant upper limb peripheral arterial disease

          -  Previous history of upper limb deep vein thrombosis

          -  Patients on glibenclamide or nicorandil (these medications may interfere with RIPC)
             Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2

          -  Patients with a known history of myocarditis, pericarditis or amyloidosis

          -  Patients with an estimated pre-operative glomerular filtration rate <
             30mls/min/1.73m2.

          -  Patients with severe hepatic disease defined as an international normalised ratio >2
             in the absence of systemic anticoagulation

          -  Patients with severe respiratory disease (for the trial, defined as patients requiring
             home oxygen therapy)

          -  Patients previously enrolled in the trial representing for a further procedure

          -  Patients with previous axillary surgery

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Stewart R Walsh, Mch FRCS, 00353 876632654, [email protected]

Location Countries

Ireland

Location Countries

Ireland

Administrative Informations

NCT ID

NCT02097186

Organization ID

SAVES-F

Responsible Party

Principal Investigator

Study Sponsor

Mid Western Regional Hospital, Ireland

Study Sponsor

Stewart R Walsh, Mch FRCS, Principal Investigator, Mid Western Regional Hospital and University of Limerick

Verification Date

December 2014