Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients

NCT ID: NCT02159456

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2021-12-31

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

Conditions

Nutrition Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Continuous enteral feeding

Continuous enteral feeding via infusion pump is applied for at least 7 days after the start of enteral feeding

Group Type: EXPERIMENTAL

Continuous enteral feeding via infusion pump

Intervention Type: OTHER

Intermittent enteral feeding

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

Group Type: ACTIVE_COMPARATOR

Intermittent enteral feeding via gravity-based infusion

Intervention Type: OTHER

Interventions

Continuous enteral feeding via infusion pump

Intervention Type: OTHER

Intermittent enteral feeding via gravity-based infusion

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jinwoo Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

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

Countries

South Korea

Other Identifiers

feed520

Identifier Type: -

Identifier Source: org_study_id