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

Not Applicable

Completed

• Conditions: Critically Ill
• Interventions: Other: Specific Enteral Nutrition; Other: Standard Enteral Nutrition

• Registration Number: NCT01581957
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-20
• Study Start: 2012-12
• Primary Completion: 2014-02
• Study Completion: 2014-04
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-26
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Specific Enteral formulation	Specific Enteral Nutrition	-
Standard enteral formulation	Standard Enteral Nutrition	-

Primary Outcome Measures

Name	Time	Method
Diarrhea-free days during Enteral Nutrition (EN) administration to the patients in the Intensive Care Unit (ICU)	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)	from EN start until end of treatment or ICU discharge (whatever comes firts)	Patients will receive treatment for 10 days maximum

Secondary Outcome Measures

Name	Time	Method
Presence/absence of other abdominal symptoms	up to 10 days	If present: description of abdominal distension, pain, absence of bowel sounds
Incidence and severity of diarrhea	up to 10 days	* 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
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
Need to use any drug interfering with the passage of nutrition	up to 10 days
Visual analogue scale for abdominal discomfort	up to 10 days	Assessed in non-comatose patients
Health Economic burden of Diarrhea during EN administration at ICU	up to 10 days	* Nurse workload for the management of patients with diarrhea during the EN feeding period in ICU; * Total cost of diarrhea evaluated for each patient who experienced diarrhea (medications, cleaning material, blankets, etc.)
For blood glucose control	up to 10 days	* Number of events outside the 4.5 to 10 mmol/l glycaemic range; * Need for insulin unit administration during exclusive enteral nutrition; * Need for glucose administration during exclusive enteral nutrition
Time to reach the full caloric goal	up to 10 days	25 Kcal/kg/day or as determined for each patient with indirect calorimetry
Accumulated daily caloric deficit during 72 hs after start of the study	up to 10 days	Percentage of cumulative calories delivered vs. prescribed during hospitalization in ICU and accumulated deficit during ICU stay/day (it should be the same)
Need for parenteral nutrition supplementation during ICU stay	up to 10 days	yes/no, economic impact
Nutritional assessment	up to 10 days	serum albumin at baseline, 3 days after EN start and at treatment end or at ICU discharge (whatever comes first)
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	Comprehensive intestinal microbiota profiling by sequencing-based approaches in stool samples collected right before initiation of EN, 3 days after EN start, at treatment end or at ICU discharge (whatever comes first), and at diarrhea episodes
Determination of diarrhea pathogenicity	up to 10 days	Infections, fecal cultures for pathogens assessed at diarrhea episodes
Safety evaluation (blood sampling)	up to 10 days	End-point of safety evaluation at baseline, 3 days after EN start and at treatment end or at ICU discharge (whatever comes first), will include: blood cell analysis, hemoglobin, hepatic enzymes and creatinine
AEs (adverse events) / SAEs (serious adverse events)	up to 28 days	AE and SAE reporting from study start until 28 days after randomization

Trial Locations

Locations (1)

Department of Intensive Care Medicine. Bern University Hospital; 🇨🇭 Bern, Switzerland