Nutrition DisordersNCT02159456
Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients
A study testing Continuous enteral feeding via infusion pump and Intermittent enteral feeding via gravity-based infusion in people with Nutrition Disorders, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Nutrition Disorders
- What is being tested?
- Continuous enteral feeding via infusion pump and Intermittent enteral feeding via gravity-based infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Daehak-ro, Jongno-gu, 110-744
About this study
Official title: Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients: a Prospective, Randomized Controlled Trial
- 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.
Read more
- 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
- Being tested
- Continuous enteral feeding via infusion pump, Intermittent enteral feeding via gravity-based infusion
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous enteral feeding via infusion pumpOther
Intermittent enteral feeding via gravity-based infusionOther
| Study group | Role | What they receive |
|---|---|---|
| Continuous enteral feeding | Experimental | Continuous enteral feeding via infusion pump is applied for at least 7 days after the start of enteral feeding Receives: 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. Receives: Other: Intermittent enteral feeding via gravity-based infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement rate of target nutritional goal
Measured: Within 7 days after the start of enteral feeding
Secondary outcomes (5)
Gastrointestinal tolerance
Measured: Within 7 days after start of enteral feeding
ICU/hospital mortality
Measured: During hospital admission
Frequency of hospital-aquired infection
Measured: During hospital admission
ICU/hospital length-of-stay
Measured: During hospital admission
Duration of mechanical ventilation
Measured: During hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinwoo Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159456
- Sponsor's protocol ID
- feed520
- Status last verified
- Aug 2021
- First submitted
- 5 Jun 2014
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients: a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02159456
- Acronym / sponsor ID
- feed520
- Conditions
- Nutrition Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous enteral feeding | Experimental | Other: Continuous enteral feeding via infusion pumpContinuous enteral feeding via infusion pump is applied for at least 7 days after the start of enteral feeding |
| Intermittent enteral feeding | Active comparator | Other: Intermittent enteral feeding via gravity-based infusionIntermittent enteral feeding via gravity-based infusion is applied for at least 7 days after the start of enteral feeding. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous enteral feeding via infusion pump | Other | Continuous enteral feeding |
| Intermittent enteral feeding via gravity-based infusion | Other | Intermittent enteral feeding |
Primary outcome
Achievement rate of target nutritional goal
Time frame: Within 7 days after the start of enteral feeding
5 secondary outcomes
Gastrointestinal tolerance
Time frame: Within 7 days after start of enteral feeding
ICU/hospital mortality
Time frame: During hospital admission
Frequency of hospital-aquired infection
Time frame: During hospital admission
ICU/hospital length-of-stay
Time frame: During hospital admission
Duration of mechanical ventilation
Time frame: During hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous enteral feeding via infusion pump and Intermittent enteral feeding via gravity-based infusion in people with Nutrition Disorders, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement rate of target nutritional goal (time frame: Within 7 days after the start of enteral feeding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.