Critical IllnessNCT03727165
Nocturnal Cyclic Enteral Nutrition Infusion Versus Continuous Infusion of Enteral Nutrition
A study testing Continuous enteral nutrition infusion and Cyclic enteral nutrition infusion in people with Critical Illness and Enteral Feeding Intolerance, run by Hospital Universitario San Ignacio at 1 site in Colombia.
Trial summary
Enteral nutrition is considered the best way to feed those who can´t be fed orally. the standard protocol of administration includes continuous infusion for 24 hours; nonetheless this support is constantly suspended which causes a decrease in the nutrition administered vs the one formulated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Enteral Feeding Intolerance, Nutrition Support
- What is being tested?
- Continuous enteral nutrition infusion and Cyclic enteral nutrition infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteColombia
- Study dates
- 11 Dec 2018to 12 Mar 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old, hospitalized in San Ignacio University Hospital intensive care unit.
- Patients with indication on enteral nutrition defined by its attending or by the Nutritional and Metabolic support team.
Who cannot join
- -If patient or legal advocate denies to sign consent to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cyclic Enteral Nutrition Versus Continuous Infusion of Enteral Nutrition in Achieving Caloric Goals: Randomized Clinical Trial
Enteral nutrition is considered the best way to feed those who can´t be fed orally. the standard protocol of administration includes continuous infusion for 24 hours; nonetheless this support is constantly suspended which causes a decrease in the nutrition administered vs the one formulated.
Therefore this randomized clinical trial attempts to compare de standard administration vs. cyclic infusion during night hours measuring the formulated vs the administered volume of enteral nutrition given to the patient.
The control group will be assigned standard 24 hour infusion of enteral nutrition while the experimental group will be assigned cyclic infusion during night hours. The variables include volume formulated, volume given in 24 hours, hours and reasons why the enteral nutrition was suspended, and related complications (abdominal distension, vomiting, and diarrhea).
Read the detailed description
The trial will be carried at San Ignacio University Hospital intensive care unit. Patients included will be over 18 years old who require enteral nutrition according to their attending or to the nutritional and metabolic support team.
260 envelopes with the specific intervention were created. 130 of them are identified with number 0 which corresponds to no intervention, meaning continuous enteral nutrition infusion during 24 hours. The other 130 are assigned with the number 1 which corresponds to intervention, meaning nocturnal cyclic nocturnal enteral nutrition infusion.
Envelopes will be randomly assigned sequentially from number 1 to 260, in which envelope number 1 will be assigned for the first patient. Each patient´s envelope will be labeled with its name and identification number. According to the information contained in the envelope the specific scheme assigned will be formulated.
Envelopes will be kept at the Nutritional and metabolic support´s office; only research assistant will have access to this information.
After 50% of the sample be achieved, there will be a data analysis to review the rate of intolerance to enteral nutrition in both groups.
Principal investigators will review the entire data after completion of the clinical trial, measuring percentage of enteral nutrition delivered and intolerance to enteral nutrition feeding.
- Being tested
- Continuous enteral nutrition infusion, Cyclic enteral nutrition infusion
- Keywords
- enteral nutrition, critically ill, continous infusion, cyclic infusion
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous enteral nutrition infusionOther
Enteral nutrition administration in continuous infusion during 24 hours per day
Cyclic enteral nutrition infusionOther
Enteral nutrition administration in continuous infusion during 16 hours per day
| Study group | Role | What they receive |
|---|---|---|
| Continuous infusion | Active comparator | Patients with continuous infusion enteral nutrition in the intensive care unit at San Ignacio University Hospital Receives: Other: Continuous enteral nutrition infusion |
| Cyclic infusion | Experimental | Patients formulated with cyclic enteral nutrition infusion, administrated at night hours, from 4pm until 7am. Receives: Other: Cyclic enteral nutrition infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enteral nutrition delivered/Enteral nutrition prescribed x 100
Enteral nutrition delivered/Enteral nutrition prescribed x 100
Measured: 24 hours
Secondary outcomes (1)
Enteral nutrition intolerance
number of patients with intolerance/total number of patients
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start11 Dec 2018
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Why it stopped: Covid pandemia.suspended study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saul J Rugeles, MD, Principal investigator, Hospital Universitario San Ignacio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727165
- Sponsor's protocol ID
- 2018/121
- Status last verified
- Mar 2024
- First submitted
- 30 Oct 2018
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclic Enteral Nutrition Versus Continuous Infusion of Enteral Nutrition in Achieving Caloric Goals: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03727165
- Acronym / sponsor ID
- 2018/121
- Keywords
- enteral nutrition, critically ill, continous infusion, cyclic infusion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid pandemia.suspended study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 1 Nov 2018 (actual)
- 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.
Enteral nutrition is considered the best way to feed those who can´t be fed orally. the standard protocol of administration includes continuous infusion for 24 hours; nonetheless this support is constantly suspended which causes a decrease in the nutrition administered vs the one formulated.
Therefore this randomized clinical trial attempts to compare de standard administration vs. cyclic infusion during night hours measuring the formulated vs the administered volume of enteral nutrition given to the patient.
The control group will be assigned standard 24 hour infusion of enteral nutrition while the experimental group will be assigned cyclic infusion during night hours. The variables include volume formulated, volume given in 24 hours, hours and reasons why the enteral nutrition was suspended, and related complications (abdominal distension, vomiting, and diarrhea).
Detailed description
The trial will be carried at San Ignacio University Hospital intensive care unit. Patients included will be over 18 years old who require enteral nutrition according to their attending or to the nutritional and metabolic support team.
260 envelopes with the specific intervention were created. 130 of them are identified with number 0 which corresponds to no intervention, meaning continuous enteral nutrition infusion during 24 hours. The other 130 are assigned with the number 1 which corresponds to intervention, meaning nocturnal cyclic nocturnal enteral nutrition infusion.
Envelopes will be randomly assigned sequentially from number 1 to 260, in which envelope number 1 will be assigned for the first patient. Each patient´s envelope will be labeled with its name and identification number. According to the information contained in the envelope the specific scheme assigned will be formulated.
Envelopes will be kept at the Nutritional and metabolic support´s office; only research assistant will have access to this information.
After 50% of the sample be achieved, there will be a data analysis to review the rate of intolerance to enteral nutrition in both groups.
Principal investigators will review the entire data after completion of the clinical trial, measuring percentage of enteral nutrition delivered and intolerance to enteral nutrition feeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion | Active comparator | Other: Continuous enteral nutrition infusionPatients with continuous infusion enteral nutrition in the intensive care unit at San Ignacio University Hospital |
| Cyclic infusion | Experimental | Other: Cyclic enteral nutrition infusionPatients formulated with cyclic enteral nutrition infusion, administrated at night hours, from 4pm until 7am. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years old, hospitalized in San Ignacio University Hospital intensive care unit.
- Patients with indication on enteral nutrition defined by its attending or by the Nutritional and Metabolic support team.
Key exclusion criteria (1 listed)
- -If patient or legal advocate denies to sign consent to participate in this study.
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 nutrition infusionEnteral nutrition administration in continuous infusion during 24 hours per day | Other | Continuous infusion |
| Cyclic enteral nutrition infusionEnteral nutrition administration in continuous infusion during 16 hours per day | Other | Cyclic infusion |
Primary outcome
Enteral nutrition delivered/Enteral nutrition prescribed x 100
Time frame: 24 hours
Enteral nutrition delivered/Enteral nutrition prescribed x 100
1 secondary outcome
Enteral nutrition intolerance
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Saul J Rugeles, MD principal investigator
Hospital Universitario San Ignacio
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 nutrition infusion and Cyclic enteral nutrition infusion in people with Critical Illness and Enteral Feeding Intolerance, run by Hospital Universitario San Ignacio at 1 site in Colombia.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 13 Mar 2024. 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 Colombia. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Enteral nutrition delivered/Enteral nutrition prescribed x 100 (time frame: 24 hours). 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 13 Mar 2024.