Humalog or Humulin for Intensive Insulin Therapy in Intensive Care Unit
Primary Purpose
Hyperglycemia
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Regular-insulin
Lispro-insulin
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia focused on measuring intensive insulin therapy, critical care patients, blood glucose concentration>180 mg/dl
Eligibility Criteria
Inclusion Criteria:
- critical care patients with blood glucose concentration >180mg/dl
Exclusion Criteria:
- insulin dependent diabetes
Sites / Locations
- University of ROme "La Sapienza" Rome Italy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Regular-insulin,
Lispro insulin
Arm Description
regular-insulin or lispro-insulin at 0.04 units/kg/hour continuous infusion crossover and random assignement
patients randomly assigned in a crossover way to one of the 2 treatments
Outcomes
Primary Outcome Measures
Extent of insulin residual effect in critical care patients
the ratio between the therapeutic effect and the glycemia reduction after insulin is discontinued
Secondary Outcome Measures
Full Information
NCT ID
NCT02165566
First Posted
May 7, 2014
Last Updated
June 16, 2014
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT02165566
Brief Title
Humalog or Humulin for Intensive Insulin Therapy in Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
intensive insulin therapy, critical care patients, blood glucose concentration>180 mg/dl
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regular-insulin,
Arm Type
Experimental
Arm Description
regular-insulin or lispro-insulin at 0.04 units/kg/hour continuous infusion crossover and random assignement
Arm Title
Lispro insulin
Arm Type
Experimental
Arm Description
patients randomly assigned in a crossover way to one of the 2 treatments
Intervention Type
Drug
Intervention Name(s)
Regular-insulin
Other Intervention Name(s)
Humulin
Intervention Description
patients are assigned in a random sequence to receive Regular-insulin or lispro-insulin infusion
Intervention Type
Drug
Intervention Name(s)
Lispro-insulin
Other Intervention Name(s)
Humalog
Intervention Description
patients are assigned in a random sequence to receive Regular-insulin or lispro-insulin infusion
Primary Outcome Measure Information:
Title
Extent of insulin residual effect in critical care patients
Description
the ratio between the therapeutic effect and the glycemia reduction after insulin is discontinued
Time Frame
patients will be followed during insulin infusion in a time frame of minutes/hours, with an expected average time of 6-8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
critical care patients with blood glucose concentration >180mg/dl
Exclusion Criteria:
insulin dependent diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico Bilotta, MD, PhD
Organizational Affiliation
Department of Anesthesiology, University of ROme "La Sapienza"
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of ROme "La Sapienza" Rome Italy
City
Rome
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
25466315
Citation
Bilotta F, Badenes R, Lolli S, Belda FJ, Einav S, Rosa G. Insulin infusion therapy in critical care patients: regular insulin vs short-acting insulin. A prospective, crossover, randomized, multicenter blind study. J Crit Care. 2015 Apr;30(2):437.e1-6. doi: 10.1016/j.jcrc.2014.10.019. Epub 2014 Oct 30.
Results Reference
derived
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Humalog or Humulin for Intensive Insulin Therapy in Intensive Care Unit
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