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OpenTrials
Completed

NCT Number: NCT02806427

Tolerance of a Calorically Dense Enteral Nutrition Formula

This prospective observational study seeks to demonstrate the ability to meet nutritional needs of a calorically dense enteral formula in critically ill patients.

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Key information

Conditions

Enteral Feeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OUHSC

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult aged > 18 years
  • Admitted to Medical ICU with expected admission of ≥ 3 days
  • Established enteral access
  • Having obtained his/her or legal representative's informed consent.

Exclusion criteria

  • Pregnant or lactating
  • Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
  • Lack of enteral access
  • Parenteral nutrition
  • Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, etc.)
  • Subject who in the Investigator's assessment cannot be expected to comply with study protocol
  • Currently participating in another conflicting clinical trial.

Treatment and study plan

Enteral Formula

Other

Primary outcomes

  1. Daily percentage of caloric nutritional goal met

    Time frame: First 3 days in the ICU

Secondary outcomes

  1. Daily percentage of protein goal met

    Time frame: First 5 days in the ICU

  2. Adverse events and serious adverse events

    Time frame: First 5 days in the ICU

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 20, 2016
Registry last updated
Jul 2, 2017

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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