Clinical trial NCT01581957: Pilot Study on Gastro-intestinal (GI) Enteral Nutrition (EN) Tolerance in Intensive Care Unit Patients
Official title: A Pilot Study to Evaluate the Effect of a Specific Enteral Formulation Designed to Improve Gastrointestinal Tolerance in the Critically Ill Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill
Keywords: Enteral nutrition, critically ill patients
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Diarrhea-free days during Enteral Nutrition (EN) administration to the patients in the Intensive Care Unit (ICU)
timeFrame: from EN start until end of treatment or ICU discharge (whatever comes first)
measure: Number of diarrhea events per day during EN administration to the patients in the Intensive Care Unit (ICU)
timeFrame: from EN start until end of treatment or ICU discharge (whatever comes firts)
Secondary outcomes:
measure: Incidence and severity of diarrhea
timeFrame: up to 10 days
measure: Presence/absence of other abdominal symptoms
timeFrame: up to 10 days
measure: Changes in intra-abdominal pressure
timeFrame: up to 10 days
measure: Incidence of nausea, vomiting and regurgitation
timeFrame: up to 10 days
measure: Gastric residual volumes (>500 ml)
timeFrame: up to 10 days
measure: Need to use any drug interfering with the passage of nutrition
timeFrame: up to 10 days
measure: Visual analogue scale for abdominal discomfort
timeFrame: up to 10 days
measure: Health Economic burden of Diarrhea during EN administration at ICU
timeFrame: up to 10 days
measure: For blood glucose control
timeFrame: up to 10 days
measure: Time to reach the full caloric goal
timeFrame: up to 10 days
measure: Accumulated daily caloric deficit during 72 hs after start of the study
timeFrame: up to 10 days
measure: Need for parenteral nutrition supplementation during ICU stay
timeFrame: up to 10 days
measure: Nutritional assessment
timeFrame: up to 10 days
measure: Incidence of secondary infections
timeFrame: up to 10 days
measure: ICU Length of Stay, days on mechanical ventilation during ICU stay (mech. ventilation-free days), hospital LOS (length of stay)
timeFrame: up to 28 days
measure: Microbiota profiling
timeFrame: up to 10 days
measure: Determination of diarrhea pathogenicity
timeFrame: up to 10 days
measure: Safety evaluation (blood sampling)
timeFrame: up to 10 days
measure: AEs (adverse events) / SAEs (serious adverse events)
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Intensive Care Medicine. Bern University Hospital
Study officials:
affiliation: Bern University Hospital
name: Stephan Jakob, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jakob SM, Butikofer L, Berger D, Coslovsky M, Takala J. A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient-the SPIRIT trial. Crit Care. 2017 Jun 10;21(1):140. doi: 10.1186/s13054-017-1730-1.