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Completed

NCT Number: NCT01581957

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

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.

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Intensive Care Medicine. Bern University Hospital

Bern, Canton of Bern, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Specific Enteral Nutrition

Other

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

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Acronym: SPIRIT

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 20, 2012
Registry last updated
Jun 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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