A study to assess the feasibility and effects of introducing remote ischaemic preconditioning in elective abdominal aorta aneurysm repair

Completed

Conditions: Topic: Cardiovascular
Subtopic: Cardiovascular (all Subtopics)
Disease: Valve Disease
Circulatory System
Aortic aneurysm and dissection

Registration Number: ISRCTN19332276

Lead Sponsor: orth Bristol NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Over a 24-month period all new patients presenting to Southmead Hospital for elective AAA repair will be invited to participate in the trial
2. Upper Age Limit 100 years; Lower Age Limit 30 years

Exclusion Criteria

1. Unable to give informed consent
2. If they are taking sulphonylurea oral hypoglycaemic drugs or nicorandil, which have been shown to influence preconditioning

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main outcomes of this pilot trial relate to the planning requirements for the multi-centre RCT, including key information on recruitment method and consent procedures and rates, patient and clinical staff acceptability and opinion, data on the logistics of the delivering the RIPC, blinding, data collection and capture, management processes, and expected variations in practice across sites. <br><br>Primary clinical outcomes recorded in the pilot trial are renal injury and myocardial injury, including arrhythmias and myocardial infarction.

Secondary Outcome Measures

Name	Time	Method
1. The length of ICU stay and duration of overall postoperative hospital stay<br>2. Incidence of stroke and death <br>3. Variation in patient-reported outcomes <br>We shall use variation in these outcomes to inform power calculations for the larger RCT, taking information on procedural differences between centres into consideration.