Nutritional and Metabolic Evaluation of a Tube Feeding Im... | NCT00560157

Studies
Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients

NCT00560157

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Nov 19, 2013Estimated

Enrollment

22Actual

Phase

Phase 4

Conditions

Neurological Diseases
Pneumopathy
Major Abdominal Surgery
Acute Pancreatitis

Interventions

Crucial (enteral tube feeding)

Countries

France

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

Nov 2013

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

Dec 2002

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Nov 6, 2007

First Submission Date that Met QC Criteria

Nov 16, 2007

First Posted Date

Nov 19, 2007Estimated

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

Nov 18, 2013

Last Update Posted Date

Nov 19, 2013Estimated

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

Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with those of a standard polymeric one, in ICU patients

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I	Active Comparator	Sondalis HP	Dietary Supplement: Crucial (enteral tube feeding)
II	Experimental	Crucial	Dietary Supplement: Crucial (enteral tube feeding)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Crucial (enteral tube feeding)	Dietary Supplement	Evaluation of new enteral product, Crucial, in ICU patients	I II

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Variation of Glutamine after 90 min of enteral product administration		J5

Secondary Outcomes

Measure	Description	Time Frame
Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stress		J1, J5, J8
Tolerance		Daily until J8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18<age<89, ASA score<4 , SAPS II score>10
requiring the administration of an exclusive tube feeding nutrition during 7 days and beginning at the latest in the three days following the aggression
ICU patients hospitalized for:
neurologic affections
pneumopathy
major abdominal surgery or serious acute pancreatitis
written informed consent

Exclusion Criteria:

pregnancy or breast feeding
immunosuppressive therapy
radiotherapy or chemotherapy in the last six month
uncontrolled septic choc
auto-immune disease
hepatic,renal or digestive insufficiency
hyperlipidemia
diabetes mellitus type 1
digestive malabsorption
life threatening situation
treatments with growing hormone, glutamine or its metabolites or precursors such as ornithine alpha keto glutarate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luc CYNOBER, PhD	University PARIS V	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital A. BECLERE		Clamart		92141	France
Hopital Saint Antoine

Condition Browse Module

MeSH Terms

ID	Term
D008171	Lung Diseases
D010195	Pancreatitis

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004750	Enteral Nutrition

Ancestor Terms

ID	Term
D005248	Feeding Methods
D013812	Therapeutics
D018529	Nutritional Support
D044623	Nutrition Therapy

Browse Leaves

Not provided

Browse Branches

Not provided