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Clinical Trials/NCT02159456
NCT02159456
Unknown
Not Applicable

Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients: a Prospective, Randomized Controlled Trial

Seoul National University Hospital1 site in 1 country70 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutrition Disorders
Sponsor
Seoul National University Hospital
Enrollment
70
Locations
1
Primary Endpoint
Achievement rate of target nutritional goal
Last Updated
4 years ago

Overview

Brief Summary

  1. Nutritional support during critical illness is important to improve the clinical outcome of patients. Recently, the apply of early enteral nutrition is recommend in critically ill patients on basis of data that enteral nutrition can be helpful to prevent the hospital-acquired infections.

    • However, in critically ill patients, the smooth progress of nutritional support is often hindered by gastrointestinal intolerance, underlying clinical condition, and temporal necessity of procedure or operation.
    • Continuous feeding method, compared with intermittent feeding, is expected to reduce the risk of gastrointestinal intolerance, and improve the nutritional support, but this hypothesis is not supported by appropriate evidences.
  2. We will elucidate to compare the efficacy and safety of the continuous feeding method in critically ill patients, compared with the intermittent feeding method.

    • Prospective, randomized controlled study
    • Primary outcome: the achievement rate of target nutritional goal within 7 days after the start of enteral nutrition
    • Secondary outcome: gastrointestinal tolerance, In-ICU/hospital mortality, frequency of hospital-acquired infection, ICU/hospital length-of-stay, duration of mechanical ventilation
Registry
clinicaltrials.gov
Start Date
May 2014
End Date
December 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jinwoo Lee

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • adult patient admitted in the intensive care unit
  • age 20 years old or more
  • The enteral nutritional support is expected to be available within 48 hours after ICU admission

Exclusion Criteria

  • previous abdominal surgery within 1 month
  • gastrointestinal bleeding, bowel obstruction, refractory vomiting/diarrhea
  • hypersensitivity to prokinetics, history of seizure or phechromocytoma
  • enteral feeding via enterostomy or gastrostomy
  • difficulty to insert or maintain nasogastric tube
  • need for specialized feeding (ex: hemodialysis diet, chronic renal failure diet, diabetes diet)
  • pregnancy

Outcomes

Primary Outcomes

Achievement rate of target nutritional goal

Time Frame: Within 7 days after the start of enteral feeding

Secondary Outcomes

  • ICU/hospital mortality(During hospital admission)
  • Gastrointestinal tolerance(Within 7 days after start of enteral feeding)
  • Frequency of hospital-aquired infection(During hospital admission)
  • ICU/hospital length-of-stay(During hospital admission)
  • Duration of mechanical ventilation(During hospital admission)

Study Sites (1)

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