search
Back to results

Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients

Primary Purpose

Nutrition Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Continuous enteral feeding via infusion pump
Intermittent enteral feeding via gravity-based infusion
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutrition Disorders

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous enteral feeding

Intermittent enteral feeding

Arm Description

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

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

Outcomes

Primary Outcome Measures

Achievement rate of target nutritional goal

Secondary Outcome Measures

Gastrointestinal tolerance
ICU/hospital mortality
Frequency of hospital-aquired infection
ICU/hospital length-of-stay
Duration of mechanical ventilation

Full Information

First Posted
June 5, 2014
Last Updated
August 18, 2021
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02159456
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous enteral feeding
Arm Type
Experimental
Arm Description
Continuous enteral feeding via infusion pump is applied for at least 7 days after the start of enteral feeding
Arm Title
Intermittent enteral feeding
Arm Type
Active Comparator
Arm Description
Intermittent enteral feeding via gravity-based infusion is applied for at least 7 days after the start of enteral feeding.
Intervention Type
Other
Intervention Name(s)
Continuous enteral feeding via infusion pump
Intervention Type
Other
Intervention Name(s)
Intermittent enteral feeding via gravity-based infusion
Primary Outcome Measure Information:
Title
Achievement rate of target nutritional goal
Time Frame
Within 7 days after the start of enteral feeding
Secondary Outcome Measure Information:
Title
Gastrointestinal tolerance
Time Frame
Within 7 days after start of enteral feeding
Title
ICU/hospital mortality
Time Frame
During hospital admission
Title
Frequency of hospital-aquired infection
Time Frame
During hospital admission
Title
ICU/hospital length-of-stay
Time Frame
During hospital admission
Title
Duration of mechanical ventilation
Time Frame
During hospital admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Daehak-ro, Jongno-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients

We'll reach out to this number within 24 hrs