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

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

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 Overview

• Status: Completed
• Conditions: Critically Ill
• Intervention / Treatment: Other: Specific Enteral Nutrition; Other: Standard Enteral Nutrition

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland
    • Department of Intensive Care Medicine. Bern University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Specific Enteral formulation	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).
Placebo Comparator: Standard enteral formulation	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Presence/absence of other abdominal symptoms	If present: description of abdominal distension, pain, absence of bowel sounds	up to 10 days
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
Need to use any drug interfering with the passage of nutrition		up to 10 days
Visual analogue scale for abdominal discomfort	Assessed in non-comatose patients	up to 10 days
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
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
Time to reach the full caloric goal	25 Kcal/kg/day or as determined for each patient with indirect calorimetry	up to 10 days
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
Need for parenteral nutrition supplementation during ICU stay	yes/no, economic impact	up to 10 days
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
Incidence of secondary infections		up to 10 days
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	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
Determination of diarrhea pathogenicity	Infections, fecal cultures for pathogens assessed at diarrhea episodes	up to 10 days
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
AEs (adverse events) / SAEs (serious adverse events)	AE and SAE reporting from study start until 28 days after randomization	up to 28 days

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Stephan Jakob, Professor, Bern University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: April 18, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Estimate): June 27, 2014
• Last Update Submitted That Met QC Criteria: June 26, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Enteral nutrition, critically ill patients
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 10.10.CLI