Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients

NCT02159456 | Unknown DMC

• 1 other identifier: feed520
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.
• 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

Conditions

Nutrition Disorders

Outcome Measures

Primary Outcomes (1)

• Achievement rate of target nutritional goal

  Within 7 days after the start of enteral feeding

Secondary Outcomes (5)

• 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

Study Arms (2)

Continuous enteral feeding

EXPERIMENTAL

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

Intermittent enteral feeding

ACTIVE COMPARATOR

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

Interventions

Continuous enteral feeding via infusion pump OTHER

Continuous enteral feeding

Intermittent enteral feeding via gravity-based infusion OTHER

Intermittent enteral feeding

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Daehak-ro, Jongno-gu, 110-744, South Korea

Location

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 10, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

KR (1)