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

Critically Ill Clinical Trial

— SPIRIT  

Official title:

A Pilot Study to Evaluate the Effect of a Specific Enteral Formulation Designed to Improve Gastrointestinal Tolerance in the Critically Ill Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581957
• Other study ID #: 10.10.CLI
• Status: Completed
• Phase: N/A
• First received: April 18, 2012
• Last updated: June 26, 2014
• Start date: December 2012
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

Other:
• 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).
• 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).

Locations

Country	Name	City	State
Switzerland	Department of Intensive Care Medicine. Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	from EN start until end of treatment or ICU discharge (whatever comes first)	No
Primary	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	from EN start until end of treatment or ICU discharge (whatever comes firts)	No
Secondary	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	up to 10 days	No
Secondary	Presence/absence of other abdominal symptoms	If present: description of abdominal distension, pain, absence of bowel sounds	up to 10 days	No
Secondary	Changes in intra-abdominal pressure		up to 10 days	No
Secondary	Incidence of nausea, vomiting and regurgitation		up to 10 days	No
Secondary	Gastric residual volumes (>500 ml)		up to 10 days	No
Secondary	Need to use any drug interfering with the passage of nutrition		up to 10 days	No
Secondary	Visual analogue scale for abdominal discomfort	Assessed in non-comatose patients	up to 10 days	No
Secondary	Health Economic burden of Diarrhea during EN administration at ICU	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.)	up to 10 days	No
Secondary	For blood glucose control	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	up to 10 days	No
Secondary	Time to reach the full caloric goal	25 Kcal/kg/day or as determined for each patient with indirect calorimetry	up to 10 days	No
Secondary	Accumulated daily caloric deficit during 72 hs after start of the study	Percentage of cumulative calories delivered vs. prescribed during hospitalization in ICU and accumulated deficit during ICU stay/day (it should be the same)	up to 10 days	No
Secondary	Need for parenteral nutrition supplementation during ICU stay	yes/no, economic impact	up to 10 days	No
Secondary	Nutritional assessment	serum albumin at baseline, 3 days after EN start and at treatment end or at ICU discharge (whatever comes first)	up to 10 days	No
Secondary	Incidence of secondary infections		up to 10 days	Yes
Secondary	ICU Length of Stay, days on mechanical ventilation during ICU stay (mech. ventilation-free days), hospital LOS (length of stay)		up to 28 days	No
Secondary	Microbiota profiling	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	up to 10 days	No
Secondary	Determination of diarrhea pathogenicity	Infections, fecal cultures for pathogens assessed at diarrhea episodes	up to 10 days	No
Secondary	Safety evaluation (blood sampling)	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	up to 10 days	Yes
Secondary	AEs (adverse events) / SAEs (serious adverse events)	AE and SAE reporting from study start until 28 days after randomization	up to 28 days	Yes