Clinical trial NCT02159456: Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients
Official title: Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients: a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition Disorders
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: Achievement rate of target nutritional goal
timeFrame: Within 7 days after the start of enteral feeding
Secondary outcomes:
measure: Gastrointestinal tolerance
timeFrame: Within 7 days after start of enteral feeding
measure: ICU/hospital mortality
timeFrame: During hospital admission
measure: Frequency of hospital-aquired infection
timeFrame: During hospital admission
measure: ICU/hospital length-of-stay
timeFrame: During hospital admission
measure: Duration of mechanical ventilation
timeFrame: During hospital admission
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Daehak-ro, Jongno-gu
Study officials:
References: