A Pilot Study to Evaluate the Effect of a Specific Enteral Formulation Designed to Improve Gastrointestinal Tolerance in the Critically Ill Patient

Société des Produits Nestlé (SPN)1 site in 1 country90 target enrollmentDecember 2012

ConditionsCritically Ill

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Critically Ill
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 90
Locations: 1
Primary Endpoint: Diarrhea-free days during Enteral Nutrition (EN) administration to the patients in the Intensive Care Unit (ICU)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Specifically designed enteral formulations may improve the gastrointestinal tolerance during early enteral nutrition in the critically ill patient.

This pilot trial will permit testing the design of the full-scale study providing valuable data on the expected effect of the formulation, the variability, thus helping to better estimate the required sample size.

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

April 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female older than 18 years of age
•All ICU patients
•Expected ICU stay superior or equal to 5 days
•Anticipated to receive tube feeding for at least 3 days
•Informed consent obtained from patient or close relative

Exclusion Criteria

•Contraindication to enteral nutrition or to the placement of an enteral feeding tube
•On enteral nutrition with superior or equal to 75% of caloric goal administered
•Restriction in full intestinal support including protein administration
•Parenteral nutrition of any kind unless due to enteral nutrition intolerance
•History of allergy or intolerance to the study product components (test or control product)
•Currently under therapeutic limitations. Non functional GI tract
•Unwilling or unable to comply with study treatments
•Currently participating or having participated in another clinical, interventional trial during the last month

Outcomes

Primary Outcomes

Diarrhea-free days during Enteral Nutrition (EN) administration to the patients in the Intensive Care Unit (ICU)

Time Frame: from EN start until end of treatment or ICU discharge (whatever comes first)

Patients will receive treatment for 10 days maximum

Number of diarrhea events per day during EN administration to the patients in the Intensive Care Unit (ICU)

Time Frame: from EN start until end of treatment or ICU discharge (whatever comes firts)

Patients will receive treatment for 10 days maximum

Secondary Outcomes

Presence/absence of other abdominal symptoms(up to 10 days)
Incidence and severity of diarrhea(up to 10 days)
Changes in intra-abdominal pressure(up to 10 days)
Incidence of nausea, vomiting and regurgitation(up to 10 days)
Gastric residual volumes (>500 ml)(up to 10 days)
Incidence of secondary infections(up to 10 days)
Visual analogue scale for abdominal discomfort(up to 10 days)
Need to use any drug interfering with the passage of nutrition(up to 10 days)
Health Economic burden of Diarrhea during EN administration at ICU(up to 10 days)
For blood glucose control(up to 10 days)
Time to reach the full caloric goal(up to 10 days)
Accumulated daily caloric deficit during 72 hs after start of the study(up to 10 days)
Need for parenteral nutrition supplementation during ICU stay(up to 10 days)
Nutritional assessment(up to 10 days)
ICU Length of Stay, days on mechanical ventilation during ICU stay (mech. ventilation-free days), hospital LOS (length of stay)(up to 28 days)
Microbiota profiling(up to 10 days)
Determination of diarrhea pathogenicity(up to 10 days)
Safety evaluation (blood sampling)(up to 10 days)
AEs (adverse events) / SAEs (serious adverse events)(up to 28 days)