Clinical trial NCT03727165: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Critical Illness
Enteral Feeding Intolerance
Nutrition Support
Keywords: enteral nutrition
critically ill
continous infusion
cyclic infusion
Lead sponsor: Hospital Universitario San Ignacio
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Enteral nutrition delivered/Enteral nutrition prescribed x 100
timeFrame: 24 hours
Secondary outcomes:
measure: Enteral nutrition intolerance
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
state: Bogota DC
Study officials:
affiliation: Hospital Universitario San Ignacio
name: Saul J Rugeles, MD
role: PRINCIPAL_INVESTIGATOR
References: