Pilot Study on Gastro-intestinal (GI) Enteral Nutrition (EN) Tolerance in Intensive Care Unit Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Specific Enteral formulation

Group Type ACTIVE_COMPARATOR

Specific Enteral Nutrition

Intervention Type OTHER

Patients will receive a Specific EN. The caloric target is 25 Kcal/kg/day to be reached on the third day post-initiation of EN (early enteral nutrition).

Standard enteral formulation

Group Type PLACEBO_COMPARATOR

Standard Enteral Nutrition

Intervention Type OTHER

Patients will receive an equivalent volume and caloric intake of standard formulation. The caloric target is 25 Kcal/kg/day to be reached on the third day post-initiation of EN (early enteral nutrition).

Interventions

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Specific Enteral Nutrition

Patients will receive a Specific EN. The caloric target is 25 Kcal/kg/day to be reached on the third day post-initiation of EN (early enteral nutrition).

Intervention Type OTHER

Standard Enteral Nutrition

Patients will receive an equivalent volume and caloric intake of standard formulation. The caloric target is 25 Kcal/kg/day to be reached on the third day post-initiation of EN (early enteral nutrition).

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No