Humalog or Humulin for Intensive Insulin Therapy in Intensive Care Unit
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Insulin preparation -random assignment to regular insulin lin or lispro insulin as first
      treatment- was administered at constant infusion rate (0.04 units/Kg/h) in patients
      presenting blood glucose concentration ≥180 mg/dl and was discontinued when blood glucose
      concentration ≤140 mg/dl (therapeutic blood glucose concentration drop). Further reduction in
      blood glucose concentration after discontinuation of insulin infusion was recorded
      (post-infusional blood glucose concentration drop). During the study period blood glucose
      concentration, in whole blood, was measured every 30 minutes. At least 6 hours interval was
      allowed between the 2 treatments.
    

Detailed description: 
      Inclusion criteria: Patients older than 18 years of age receiving full nutritional calories
      supply who presented blood glucose concentration ≥180 mg/dl. Exclusion criteria: moribund
      patients and patients enrolled on other studies were excluded. Patients with type 1 diabetes,
      patients with insulin-dependent diabetes are excluded and patients with glycated hemoglobin
      (glycosilated hemoglobin) >5.6% are also excluded because of the potential of underlying
      insulin resistance.

      A randomized crossover design is used. Patients receiving insulin infusion therapy are
      prospectively enrolled and randomly assigned to start the treatment either with lispro
      insulin or regular insulin at a dose of 0.04 units/Kg/h. After full enteral or parenteral
      nutrition is established, the insulin infusion therapy is started if blood glucose
      concentration ≥180 mg/dl (upper blood glucose concentration threshold) and is kept constant
      until blood glucose concentration is ≤140 mg/dl (lower blood glucose concentration
      threshold). Insulin infusion is discontinued after the blood glucose concentration reached
      ≤140 mg/dl. Because of the crossover design of the study, the same patient is treated with
      both lispro insulin or regular insulin infusion allowing an interval of at least 6 hours
      between the 2 treatments. During the study period -IIT and after insulin infusion is
      discontinued- the blood glucose concentration is measured every 30 minutes in whole blood
      (with blood gas analysis) until blood glucose concentration values return within the target
      threshold (140-180 mg/dl). The primary outcome measure was the extent of "residual effect"
      after that insulin (Hlog or Hlin) infusion has been discontinued. This variable is expressed
      as the ratio between blood glucose concentration reduction during insulin infusion (from the
      beginning of insulin infusion for blood glucose concentration values >180 mg/dl, to the first
      measurement ≤140 mg/dl) and blood glucose concentration reduction after insulin infusion is
      discontinued (from the first blood glucose concentration value ≤140 mg/dl to the lowest blood
      glucose concentration value recorded). Secondary end point measures are: rate of blood
      glucose concentration reduction during insulin infusion (mg/dl/h-1), duration of the
      "residual effect" (time elapsed between insulin infusion discontinuation and the lowestblood
      glucose concentration value), and the rate of blood glucose concentration increase from
      lowest blood glucose concentration value to the first blood glucose concentration value ≥140
      mg/dl.
    

Intervention name(s): Regular-insulin; Lispro-insulin
Intervention type(s): Drug; Drug
Intervention description(s): patients are assigned in a random sequence to receive Regular-insulin or lispro-insulin infusion; patients are assigned in a random sequence to receive Regular-insulin or lispro-insulin infusion
Other intervention name(s): Humulin; Humalog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intensive insulin therapy; critical care patients; blood glucose concentration>180 mg/dl