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A prospective multi-center randomized controlled trial: intensive insulin therapy in severely burned patients

A prospective multi-center randomized controlled trial: intensive insulin therapy in severely burned patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12001906
Enrollment
Unknown
Registered
2012-02-03
Start date
2011-12-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

burns

Interventions

1:intensive insulin therapy: maintain blood glucose level between 4.4mmol/L and 7 mmol/L
2:conventional insulin therapy: maintain blood glucose level between 7mmol/L and 10 mmol/L

Sponsors

The First Affiliated Hospital of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 60; 2. Thermally injured patients; 3. Burns more than 30% of total body surface area (TBSA); 4. Admission within 72 hours after thermally injury.

Exclusion criteria

Exclusion criteria: 1. Burned patients but non-thermally injured (electric burn, chemical injury, radical injury, et al); 2. Patients with severe cardiac, hepatic or renal dysfunction before injury (cardiac function classification, by NYHA, grade III or IV; total bilirubin >=33umol/L; creatinine>=171umol/L or urine output<=500ml/24h); 3. Pregnant or lactating women; 4. Patients would be treated in other department for severe multitrauma; 5. Patients treated with glucocorticoid for other disease; 6. Patients with type 1 diabetes mellitus, diabetic ketoacidosis or nonketotic hyperosmolar diabetic coma; 7. Patients treated with immunosuppressive agents; 8. Patients with a life expectancy less than 24 h; 9. Patients who are participating or have participated in other clinical trials within 1 month before this trial; 10. Drug addicts or heavy drinkers; 11. Patients who can not provide prior informed consent or delayed informed consent.

Design outcomes

Primary

MeasureTime frame
Mortality (28 days mortality, 60-days mortality, 90-days);sepsis morbidity;incidence of hypoglycemia;

Secondary

MeasureTime frame
Length of hospital stay;incidence of organ dysfunction;duration of mechanical ventilation support;duration of renal replacement therapy;incidence of infection;rate of burn wound healing;metabolic index;immune index;coagulation index;

Countries

China

Contacts

Public ContactJiake Chai
cjk304@126.com+86 13601057978

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026