Topic: Cardiovascular
Conditions
Interventions
60 subjects: 30 undergoing elective abdominal aneurysm repair via the traditional open procedure (15 in RIPC arm and 15 controls)
30 undergoing endovascular aorta aneurysm repair (EVAR) with again 15
Sponsors
North Bristol NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Primary clinical outcomes recorded in the pilot trial are renal injury and myocardial injury, including arrhythmias and myocardial infarction. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The length of ICU stay and duration of overall postoperative hospital stay 2. Incidence of stroke and death 3. Variation in patient-reported outcomes We shall use variation in these outcomes to inform power calculations for the larger RCT, taking information on procedural differences between centres into consideration. | — |
Countries
United Kingdom
Outcome results
None listed