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Nocturnal Cyclic Enteral Nutrition Infusion Versus Continuous Infusion of Enteral Nutrition

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ClinicalTrials.gov Identifier: NCT03727165
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario San Ignacio

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).


Condition or disease Intervention/treatment Phase
Critical Illness Enteral Feeding Intolerance Nutrition Support Other: Continuous enteral nutrition infusion Other: Cyclic enteral nutrition infusion Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Triple (Participant, Care Provider, Outcomes 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
Primary Purpose: Treatment
Official Title: Cyclic Enteral Nutrition Versus Continuous Infusion of Enteral Nutrition in Achieving Caloric Goals: Randomized Clinical Trial
Actual Study Start Date : December 11, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Active Comparator: Continuous infusion
Patients with continuous infusion enteral nutrition in the intensive care unit at San Ignacio University Hospital
Other: Continuous enteral nutrition infusion
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.
Other: Cyclic enteral nutrition infusion
Enteral nutrition administration in continuous infusion during 16 hours per day




Primary Outcome Measures :
  1. Enteral nutrition delivered/Enteral nutrition prescribed x 100 [ Time Frame: 24 hours ]
    Enteral nutrition delivered/Enteral nutrition prescribed x 100


Secondary Outcome Measures :
  1. Enteral nutrition intolerance [ Time Frame: 24 hours ]
    number of patients with intolerance/total number of patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727165


Contacts
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Contact: María M Manrique, MSC 5715946161 ext 2475 mmmanrique@husi.org.co
Contact: Saul J Rugeles, MD 5715946161 ext 2214 sjrugeles@husi.org.co

Locations
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Colombia
Hospital Universitario San Ignacio Recruiting
Bogota, Bogota DC, Colombia, 110111
Contact: Maria M Manrique, MSC    5715946161 ext 2475    mmmanrique@husi.org.co   
Sponsors and Collaborators
Hospital Universitario San Ignacio
Investigators
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Principal Investigator: Saul J Rugeles, MD Hospital Universitario San Ignacio

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Responsible Party: Hospital Universitario San Ignacio
ClinicalTrials.gov Identifier: NCT03727165     History of Changes
Other Study ID Numbers: 2018/121
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitario San Ignacio:
enteral nutrition
critically ill
continous infusion
cyclic infusion
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes