Study to assess the impact of insulin on reperfusion injury after skeletal muscle ischaemia

A randomized placebo controlled trial on the effect of insulin in reducing skeletal muscle reperfusion injury.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2014/005

Enrollment

Registered

2014-02-21

Start date

2014-04-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reperfusion injury

Interventions

Consenting participants will be randomized into two arms. The intervention arm will receive at the point of diagnosis a glucose-insulin-potassium (GIK) infusion (40 mmol KCl, in 1 liter of 10% dextr

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Absolute difference from baseline (pre perfusion) concentration of 1.Tumour Necrosis Factor (TNF)-alpha 2.Myeloperoxidase 3.Soluble P- Selectin 4.Serum Potassium 5.Serum Lactate Dehydrogenase 6.Serum Creatinephosphokinase 7.C-Reactive Protein [Pre perfusion (baseline) and post-perfusion at 0, +2, +4, +6, +12 hours post-reperfusion]	—

Secondary

Measure	Time frame
1. Non cardiogenic pulmonary oedema determined by the presence of dyspnoea, orthopnoea, bi-basal lung fine crepitations 2. Acute tubular necrosis determined by the presence of oliguric renal failure despite adequate hydration with elevated serum creatine and urea 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) 4. Fasciotomy 5. Major amputation 6. Death [at 48 hours post reperfusion]	—

Measure

Time frame

1. Non cardiogenic pulmonary oedema determined by the presence of dyspnoea, orthopnoea, bi-basal lung fine crepitations 2. Acute tubular necrosis determined by the presence of oliguric renal failure despite adequate hydration with elevated serum creatine and urea 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) 4. Fasciotomy 5. Major amputation 6. Death [at 48 hours post reperfusion]

—

Countries

Sri Lanka

Contacts

Public ContactDr. Thushan Gooneratne

Registrar in Surgery

thushey@hotmail.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026