Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients

Not Applicable

• Conditions: Nutrition Disorders
• Interventions: Other: Continuous enteral feeding via infusion pump; Other: Intermittent enteral feeding via gravity-based infusion

• Registration Number: NCT02159456
• Lead Sponsor: Seoul National University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-06-08
• Study First Posted: 2014-06-10
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-24
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous enteral feeding	Continuous enteral feeding via infusion pump	Continuous enteral feeding via infusion pump is applied for at least 7 days after the start of enteral feeding
Intermittent enteral feeding	Intermittent enteral feeding via gravity-based infusion	Intermittent enteral feeding via gravity-based infusion is applied for at least 7 days after the start of enteral feeding.

Primary Outcome Measures

Name	Time	Method
Achievement rate of target nutritional goal	Within 7 days after the start of enteral feeding

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	During hospital admission
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Daehak-ro, Jongno-gu, Korea, Republic of