Humalog or Humulin for Intensive Insulin Therapy in Intensive Care Unit

NCT02165566 | Completed Phase 4 DMC

• 1 other identifier: HlogHlin
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia

Keywords

intensive insulin therapy; critical care patients; blood glucose concentration>180 mg/dl

Outcome Measures

Primary Outcomes (1)

• Extent of insulin residual effect in critical care patients

  the ratio between the therapeutic effect and the glycemia reduction after insulin is discontinued

  patients will be followed during insulin infusion in a time frame of minutes/hours, with an expected average time of 6-8 hours

Study Arms (2)

Regular-insulin,

EXPERIMENTAL

regular-insulin or lispro-insulin at 0.04 units/kg/hour continuous infusion crossover and random assignement

Drug: Regular-insulin

Lispro insulin

EXPERIMENTAL

patients randomly assigned in a crossover way to one of the 2 treatments

Drug: Lispro-insulin

Interventions

Regular-insulin DRUG

patients are assigned in a random sequence to receive Regular-insulin or lispro-insulin infusion

Also known as: Humulin

Regular-insulin,

Lispro-insulin DRUG

patients are assigned in a random sequence to receive Regular-insulin or lispro-insulin infusion

Also known as: Humalog

Lispro insulin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• critical care patients with blood glucose concentration \>180mg/dl

You may not qualify if:

• insulin dependent diabetes

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

University of ROme "La Sapienza" Rome Italy

Rome, Italy

Location

Related Publications (1)

• 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.

  PMID: 25466315 DERIVED

MeSH Terms

Conditions

Hyperglycemia

Interventions

Insulin; Insulin, Regular, Human; Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Federico Bilotta, MD, PhD

  Department of Anesthesiology, University of ROme "La Sapienza"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: June 17, 2014
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 17, 2014

Record last verified: 2014-06

Locations

IT (1)