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

N/ACompletedNCT01581957

Société des Produits Nestlé (SPN)90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Critically Ill

Interventions

Specific Enteral NutritionOTHER

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 NutritionOTHER

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Intensive Care Medicine. Bern University Hospital

Bern, Canton of Bern, Switzerland

Outcomes

Primary Outcomes

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

Patients will receive treatment for 10 days maximum

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

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

Patients will receive treatment for 10 days maximum

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

Secondary Outcomes

Incidence and severity of diarrhea

* Number of patients that experienced diarrhea during ICU stay * Interruption of EN due to diarrhea * Presence/absence of electrolyte and acid-base disturbances secondary to diarrhea

Time frame: up to 10 days

Presence/absence of other abdominal symptoms

If present: description of abdominal distension, pain, absence of bowel sounds

Time frame: up to 10 days

Changes in intra-abdominal pressure

Time frame: up to 10 days

Incidence of nausea, vomiting and regurgitation

Time frame: up to 10 days

Gastric residual volumes (>500 ml)

Time frame: up to 10 days

Need to use any drug interfering with the passage of nutrition

Time frame: up to 10 days

Visual analogue scale for abdominal discomfort

Data from ClinicalTrials.gov

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