Nocturnal Cyclic Enteral Nutrition Infusion Versus Continuous Infusion of Enteral Nutrition
NCT ID: NCT03727165
Last Updated: 2024-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-12-11
2024-03-12
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Continuous infusion
Patients with continuous infusion enteral nutrition in the intensive care unit at San Ignacio University Hospital
Continuous enteral nutrition infusion
Enteral nutrition administration in continuous infusion during 24 hours per day
Cyclic infusion
Patients formulated with cyclic enteral nutrition infusion, administrated at night hours, from 4pm until 7am.
Cyclic enteral nutrition infusion
Enteral nutrition administration in continuous infusion during 16 hours per day
Interventions
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Continuous enteral nutrition infusion
Enteral nutrition administration in continuous infusion during 24 hours per day
Cyclic enteral nutrition infusion
Enteral nutrition administration in continuous infusion during 16 hours per day
Eligibility Criteria
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Inclusion Criteria
* Patients with indication on enteral nutrition defined by its attending or by the Nutritional and Metabolic support team.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hospital Universitario San Ignacio
OTHER
Responsible Party
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Principal Investigators
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Saul J Rugeles, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario San Ignacio
Locations
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Hospital Universitario San Ignacio
Bogotá, Bogota DC, Colombia
Countries
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Other Identifiers
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2018/121
Identifier Type: -
Identifier Source: org_study_id
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