Study to assess the impact of insulin on reperfusion injury after skeletal muscle ischaemia
Phase 2
- Conditions
- Reperfusion injury
- Registration Number
- SLCTR/2014/005
- Lead Sponsor
- Professorial Surgical Unit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1. Patients undergoing a vascular surgical intervention requiring clamping of aortic / iliac or femoral blood vessels for more than 30 minutes duration and/or
2. Patients with acute limb ischaemia, (Class ll Acute Limb Ischaemia, Society for Vascular Surgery) needing revascularization.
Exclusion Criteria
1. Patients with any of the following.
a)Insulin-treated diabetes mellitus
b)glucocorticoid treatment
c)systemic infection
d)congestive heart failure.
2. Patients for whom amputation rather than revascularization is indicated.
3. Patients below the age of 18 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute difference from baseline (pre perfusion) concentration of<br>1.Tumour Necrosis Factor (TNF)-alpha <br><br>2.Myeloperoxidase<br><br>3.Soluble P- Selectin <br><br>4.Serum Potassium<br><br>5.Serum Lactate Dehydrogenase<br><br>6.Serum Creatinephosphokinase<br><br>7.C-Reactive Protein [Pre perfusion (baseline) and post-perfusion at 0, +2, +4, +6, +12 hours post-reperfusion]<br>
- Secondary Outcome Measures
Name Time Method 1. Non cardiogenic pulmonary oedema determined by the presence of dyspnoea, orthopnoea, bi-basal lung fine crepitations <br><br>2. Acute tubular necrosis determined by the presence of oliguric renal failure despite adequate hydration with elevated serum creatine and urea<br><br>3. Compartment pressures via compartment pressure manometry when clinically determined. Clinical evidence of compartment syndrome includes assessment of colour, warmth, pulses, sensation and muscle weakness) <br><br>4. Fasciotomy<br><br>5. Major amputation<br><br>6. Death<br> [at 48 hours post reperfusion]<br>