Nocturnal Cyclic Enteral Nutrition Infusion Versus Continuous Infusion of Enteral Nutrition

Sponsor

Hospital Universitario San Ignacio (Other)

Overall Status

Suspended

CT.gov ID

NCT03727165

Collaborator

(none)

260

Enrollment

Location

Arms

43.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Enteral Feeding Intolerance Nutrition Support	Other: Continuous enteral nutrition infusion Other: Cyclic enteral nutrition infusion	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized clinical trialRandomized 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 :

Dec 11, 2018

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Enteral nutrition delivered/Enteral nutrition prescribed x 100 [24 hours]
Enteral nutrition delivered/Enteral nutrition prescribed x 100

Secondary Outcome Measures

Enteral nutrition intolerance [24 hours]
number of patients with intolerance/total number of patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario San Ignacio	Bogota	Bogota DC	Colombia	110111

Sponsors and Collaborators

Hospital Universitario San Ignacio

Investigators

Principal Investigator: Saul J Rugeles, MD, Hospital Universitario San Ignacio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital Universitario San Ignacio

ClinicalTrials.gov Identifier:

NCT03727165

Other Study ID Numbers:

2018/121

First Posted:

Nov 1, 2018

Last Update Posted:

Aug 5, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospital Universitario San Ignacio

Additional relevant MeSH terms:

Critical Illness

Study Results

No Results Posted as of Aug 5, 2020