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

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ClinicalTrials.gov Identifier: NCT01581957
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Nestlé

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.


Condition or disease Intervention/treatment Phase
Critically Ill Other: Specific Enteral Nutrition Other: Standard Enteral Nutrition Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : December 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : April 2014

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).



Primary Outcome Measures :
  1. Diarrhea-free days during Enteral Nutrition (EN) administration to the patients in the Intensive Care Unit (ICU) [ Time Frame: from EN start until end of treatment or ICU discharge (whatever comes first) ]
    Patients will receive treatment for 10 days maximum

  2. Number of diarrhea events per day during EN administration to the patients in the Intensive Care Unit (ICU) [ Time Frame: from EN start until end of treatment or ICU discharge (whatever comes firts) ]
    Patients will receive treatment for 10 days maximum


Secondary Outcome Measures :
  1. Incidence and severity of diarrhea [ Time Frame: 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

  2. Presence/absence of other abdominal symptoms [ Time Frame: up to 10 days ]
    If present: description of abdominal distension, pain, absence of bowel sounds

  3. Changes in intra-abdominal pressure [ Time Frame: up to 10 days ]
  4. Incidence of nausea, vomiting and regurgitation [ Time Frame: up to 10 days ]
  5. Gastric residual volumes (>500 ml) [ Time Frame: up to 10 days ]
  6. Need to use any drug interfering with the passage of nutrition [ Time Frame: up to 10 days ]
  7. Visual analogue scale for abdominal discomfort [ Time Frame: up to 10 days ]
    Assessed in non-comatose patients

  8. Health Economic burden of Diarrhea during EN administration at ICU [ Time Frame: 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.)

  9. For blood glucose control [ Time Frame: 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

  10. Time to reach the full caloric goal [ Time Frame: up to 10 days ]
    25 Kcal/kg/day or as determined for each patient with indirect calorimetry

  11. Accumulated daily caloric deficit during 72 hs after start of the study [ Time Frame: 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)

  12. Need for parenteral nutrition supplementation during ICU stay [ Time Frame: up to 10 days ]
    yes/no, economic impact

  13. Nutritional assessment [ Time Frame: up to 10 days ]
    serum albumin at baseline, 3 days after EN start and at treatment end or at ICU discharge (whatever comes first)

  14. Incidence of secondary infections [ Time Frame: up to 10 days ]
  15. 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 ]
  16. Microbiota profiling [ Time Frame: 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

  17. Determination of diarrhea pathogenicity [ Time Frame: up to 10 days ]
    Infections, fecal cultures for pathogens assessed at diarrhea episodes

  18. Safety evaluation (blood sampling) [ Time Frame: 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

  19. AEs (adverse events) / SAEs (serious adverse events) [ Time Frame: up to 28 days ]
    AE and SAE reporting from study start until 28 days after randomization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581957


Locations
Switzerland
Department of Intensive Care Medicine. Bern University Hospital
Bern, Switzerland
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Stephan Jakob, Professor Bern University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01581957     History of Changes
Other Study ID Numbers: 10.10.CLI
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: June 27, 2014
Last Verified: June 2014

Keywords provided by Nestlé:
Enteral nutrition, critically ill patients

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes