Tight Glycemic Control and Insulin Administration During... | NCT02035943

Studies
Tight Glycemic Control and Insulin Administration During Parenteral Nutrition

NCT02035943

Sponsor

Policlinico Hospital

Status

Completed

Last Update Posted

Jan 14, 2014Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Critical Ill Patient Undergone Parenteral Nutrition

Interventions

Insulin separated
Insulin added to parenteral nutrition

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Dec 1, 2011

First Submission Date that Met QC Criteria

Jan 13, 2014

First Posted Date

Jan 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2014

Last Update Posted Date

Jan 14, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Insulin separated	Active Comparator	Seprated infusion of insulin	Dietary Supplement: Insulin separated
Insulin added to parenteral nutrition	Active Comparator	Insulin added to parenteral nutrition	Dietary Supplement: Insulin added to parenteral nutrition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin separated	Dietary Supplement	separate continuos infusion of insulin	Insulin separated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Critical ill patients undergone parenteral nutrition

Exclusion Criteria:

Acute cerebral injury, pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sergio De Chiara, MD	Policlinico Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Policlinico Hospital		Milan	MI	20122	Italy