Tight Glycemic Control and Insulin Administration During Parenteral Nutrition

Tight Glycemic Control and Insulin Administration During Parenteral Nutrition, in Critical Ill Patients

In this study the investigators want to comare safety and efficacy of two different metods to administrate insulin during parenteral nutrition.

Study Overview

• Status: Completed
• Conditions: Critical Ill Patient Undergone Parenteral Nutrition
• Intervention / Treatment: Dietary supplement: Insulin separated; Dietary supplement: Insulin added to parenteral nutrition

Detailed Description

In this study the investigators want to compare safety and efficacy of two different metods to administrate insulin during parenteral nutrition.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20122
      • Policlinico Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Critical ill patients undergone parenteral nutrition

Exclusion Criteria:

• Acute cerebral injury, pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Insulin separated; Seprated infusion of insulin	Dietary supplement: Insulin separated; separate continuos infusion of insulin
Active Comparator: Insulin added to parenteral nutrition	Dietary supplement: Insulin added to parenteral nutrition; Insulin added to parenteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of glucose level control out of range (80-110 mg/dl)	ICU stay (a week on average)

Collaborators and Investigators

• Sponsor: Policlinico Hospital
• Investigators: Principal Investigator: Sergio De Chiara, MD, Policlinico Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: December 1, 2011
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Estimate): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 13, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 127 (Tumor Vaccine Group)