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

Nestlé

Status

Completed

Conditions

Critically Ill

Treatments

Other: Standard Enteral Nutrition

Other: Specific Enteral Nutrition

Study type

Interventional

Funder types

Industry

Identifiers

NCT01581957

10.10.CLI

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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