Nocturnal Cyclic Enteral Nutrition Infusion Versus Continuous Infusion of Enteral Nutrition
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).
Study Overview
Status
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bogota DC
-
Bogota, Bogota DC, Colombia, 110111
- Hospital Universitario San Ignacio
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
-If patient or legal advocate denies to sign consent to participate in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Continuous infusion
Patients with continuous infusion enteral nutrition in the intensive care unit at San Ignacio University Hospital
|
Enteral nutrition administration in continuous infusion during 24 hours per day
|
|
Experimental: Cyclic infusion
Patients formulated with cyclic enteral nutrition infusion, administrated at night hours, from 4pm until 7am.
|
Enteral nutrition administration in continuous infusion during 16 hours per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enteral nutrition delivered/Enteral nutrition prescribed x 100
Time Frame: 24 hours
|
Enteral nutrition delivered/Enteral nutrition prescribed x 100
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enteral nutrition intolerance
Time Frame: 24 hours
|
number of patients with intolerance/total number of patients
|
24 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Saul J Rugeles, MD, Hospital Universitario San Ignacio
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/121
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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