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

Primary Purpose

Critically Ill

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Specific Enteral Nutrition
Standard Enteral Nutrition
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critically Ill focused on measuring Enteral nutrition, critically ill patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Intensive Care Medicine. Bern University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Specific Enteral formulation

Standard enteral formulation

Arm Description

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
Presence/absence of other abdominal symptoms
If present: description of abdominal distension, pain, absence of bowel sounds
Changes in intra-abdominal pressure
Incidence of nausea, vomiting and regurgitation
Gastric residual volumes (>500 ml)
Need to use any drug interfering with the passage of nutrition
Visual analogue scale for abdominal discomfort
Assessed in non-comatose patients
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.)
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
Time to reach the full caloric goal
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
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
yes/no, economic impact
Nutritional assessment
serum albumin at baseline, 3 days after EN start and at treatment end or at ICU discharge (whatever comes first)
Incidence of secondary infections
ICU Length of Stay, days on mechanical ventilation during ICU stay (mech. ventilation-free days), hospital LOS (length of stay)
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
Determination of diarrhea pathogenicity
Infections, fecal cultures for pathogens assessed at diarrhea episodes
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
AEs (adverse events) / SAEs (serious adverse events)
AE and SAE reporting from study start until 28 days after randomization

Full Information

First Posted
April 18, 2012
Last Updated
June 26, 2014
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT01581957
Brief Title
Pilot Study on Gastro-intestinal (GI) Enteral Nutrition (EN) Tolerance in Intensive Care Unit Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
Keywords
Enteral nutrition, critically ill patients

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Jakob, Professor
Organizational Affiliation
Bern University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Intensive Care Medicine. Bern University Hospital
City
Bern
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28599662
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.
Results Reference
derived

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

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