Nocturnal Cyclic Enteral Nutrition Infusion Versus Continuous Infusion of Enteral Nutrition
Primary Purpose
Critical Illness, Enteral Feeding Intolerance, Nutrition Support
Status
Suspended
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Continuous enteral nutrition infusion
Cyclic enteral nutrition infusion
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring enteral nutrition, critically ill, continous infusion, cyclic infusion
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario San Ignacio
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Continuous infusion
Cyclic infusion
Arm Description
Patients with continuous infusion enteral nutrition in the intensive care unit at San Ignacio University Hospital
Patients formulated with cyclic enteral nutrition infusion, administrated at night hours, from 4pm until 7am.
Outcomes
Primary Outcome Measures
Enteral nutrition delivered/Enteral nutrition prescribed x 100
Enteral nutrition delivered/Enteral nutrition prescribed x 100
Secondary Outcome Measures
Enteral nutrition intolerance
number of patients with intolerance/total number of patients
Full Information
NCT ID
NCT03727165
First Posted
October 30, 2018
Last Updated
August 3, 2020
Sponsor
Hospital Universitario San Ignacio
1. Study Identification
Unique Protocol Identification Number
NCT03727165
Brief Title
Nocturnal Cyclic Enteral Nutrition Infusion Versus Continuous Infusion of Enteral Nutrition
Official Title
Cyclic Enteral Nutrition Versus Continuous Infusion of Enteral Nutrition in Achieving Caloric Goals: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Suspended
Why Stopped
Covid pandemia. Is one temporal decision.
Study Start Date
December 11, 2018 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario San Ignacio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Enteral Feeding Intolerance, Nutrition Support
Keywords
enteral nutrition, critically ill, continous infusion, cyclic infusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participants will be in the intensive care unit under sedative treatment and will not know about randomization Nurses in the intensive care unit (care providers of enteral nutrition infusion) will not know about the study Outcomes evaluation will be made by one independent clinical epidemiologist
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Continuous infusion
Arm Type
Active Comparator
Arm Description
Patients with continuous infusion enteral nutrition in the intensive care unit at San Ignacio University Hospital
Arm Title
Cyclic infusion
Arm Type
Experimental
Arm Description
Patients formulated with cyclic enteral nutrition infusion, administrated at night hours, from 4pm until 7am.
Intervention Type
Other
Intervention Name(s)
Continuous enteral nutrition infusion
Intervention Description
Enteral nutrition administration in continuous infusion during 24 hours per day
Intervention Type
Other
Intervention Name(s)
Cyclic enteral nutrition infusion
Intervention Description
Enteral nutrition administration in continuous infusion during 16 hours per day
Primary Outcome Measure Information:
Title
Enteral nutrition delivered/Enteral nutrition prescribed x 100
Description
Enteral nutrition delivered/Enteral nutrition prescribed x 100
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Enteral nutrition intolerance
Description
number of patients with intolerance/total number of patients
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saul J Rugeles, MD
Organizational Affiliation
Hospital Universitario San Ignacio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario San Ignacio
City
Bogota
State/Province
Bogota DC
ZIP/Postal Code
110111
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nocturnal Cyclic Enteral Nutrition Infusion Versus Continuous Infusion of Enteral Nutrition
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