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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01581957
First received: April 18, 2012
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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 Intervention
Critically Ill
Other: Specific Enteral Nutrition
Other: Standard Enteral Nutrition

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

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) [ Time Frame: from EN start until end of treatment or ICU discharge (whatever comes firts) ] [ Designated as safety issue: No ]
    Patients will receive treatment for 10 days maximum


Secondary Outcome Measures:
  • Incidence and severity of diarrhea [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
    If present: description of abdominal distension, pain, absence of bowel sounds

  • Changes in intra-abdominal pressure [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
  • Incidence of nausea, vomiting and regurgitation [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
  • Gastric residual volumes (>500 ml) [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
  • Need to use any drug interfering with the passage of nutrition [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
  • Visual analogue scale for abdominal discomfort [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
    Assessed in non-comatose patients

  • Health Economic burden of Diarrhea during EN administration at ICU [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
    yes/no, economic impact

  • Nutritional assessment [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
    serum albumin at baseline, 3 days after EN start and at treatment end or at ICU discharge (whatever comes first)

  • Incidence of secondary infections [ Time Frame: up to 10 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Microbiota profiling [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
    Infections, fecal cultures for pathogens assessed at diarrhea episodes

  • Safety evaluation (blood sampling) [ Time Frame: up to 10 days ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
    AE and SAE reporting from study start until 28 days after randomization


Enrollment: 90
Study Start Date: December 2012
Study Completion Date: April 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01581957     History of Changes
Other Study ID Numbers: 10.10.CLI
Study First Received: April 18, 2012
Last Updated: June 26, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Nestlé:
Enteral nutrition, critically ill patients

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014