Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Nutrition Disorders
• Intervention / Treatment: Other: Continuous enteral feeding via infusion pump; Other: Intermittent enteral feeding via gravity-based infusion

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daehak-ro, Jongno-gu
    • Seoul, Daehak-ro, Jongno-gu, Korea, Republic of, 110-744
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Continuous enteral feeding; Continuous enteral feeding via infusion pump is applied for at least 7 days after the start of enteral feeding	Other: Continuous enteral feeding via infusion pump
ACTIVE_COMPARATOR: Intermittent enteral feeding; Intermittent enteral feeding via gravity-based infusion is applied for at least 7 days after the start of enteral feeding.	Other: Intermittent enteral feeding via gravity-based infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Achievement rate of target nutritional goal	Within 7 days after the start of enteral feeding

Secondary Outcome Measures

Outcome Measure	Time Frame
Gastrointestinal tolerance	Within 7 days after start of enteral feeding
ICU/hospital mortality	During hospital admission
Frequency of hospital-aquired infection	During hospital admission
ICU/hospital length-of-stay	During hospital admission
Duration of mechanical ventilation	During hospital admission

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: June 5, 2014
• First Submitted That Met QC Criteria: June 8, 2014
• First Posted (ESTIMATE): June 10, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders
• Other Study ID Numbers: feed520