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

NCT01581957 | Completed

• 1 other identifier: 10.10.CLI
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill

Keywords

Enteral nutrition, critically ill patients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (19)

• Incidence and severity of diarrhea

  up to 10 days

• Presence/absence of other abdominal symptoms

  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

Study Arms (2)

Specific Enteral formulation

ACTIVE COMPARATOR

Other: Specific Enteral Nutrition

Standard enteral formulation

PLACEBO COMPARATOR

Other: Standard Enteral Nutrition

Interventions

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).

Specific Enteral formulation

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).

Standard enteral formulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Department of Intensive Care Medicine. Bern University Hospital

Bern, Canton of Bern, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 28599662 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephan Jakob, Professor

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: April 20, 2012
• Study Start: December 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 27, 2014

Record last verified: 2014-06

Locations

CH (1)