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Tight Glycemic Control and Insulin Administration During Parenteral Nutrition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035943
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital

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

Condition or disease Intervention/treatment Phase
Critical Ill Patient Undergone Parenteral Nutrition Dietary Supplement: Insulin separated Dietary Supplement: Insulin added to parenteral nutrition Not Applicable

Detailed Description:
In this study the investigators want to compare safety and efficacy of two different metods to administrate insulin during parenteral nutrition.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Tight Glycemic Control and Insulin Administration During Parenteral Nutrition, in Critical Ill Patients
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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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
Insulin added to parenteral nutrition
 Dietary Supplement: Insulin added to parenteral nutrition
Insulin added to parenteral nutrition


Outcome Measures
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Primary Outcome Measures :
  1. Number of glucose level control out of range (80-110 mg/dl) [ Time Frame: ICU stay (a week on average) ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Critical ill patients undergone parenteral nutrition

Exclusion Criteria:

  • Acute cerebral injury, pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035943


Locations
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Italy
Policlinico Hospital
Milano, MI, Italy, 20122
Sponsors and Collaborators
Policlinico Hospital
Investigators
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Principal Investigator: Sergio De Chiara, MD Policlinico Hospital
More Information
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Responsible Party: Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT02035943    
Other Study ID Numbers: 127
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs