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NCT03727165 Clinical Trial

Nocturnal Cyclic Enteral Nutrition Infusion Versus Continuous Infusion of Enteral Nutrition

Critical Illness Clinical Trial

Official title:
Cyclic Enteral Nutrition Versus Continuous Infusion of Enteral Nutrition in Achieving Caloric Goals: Randomized Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03727165
Other study ID # 2018/121
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 11, 2018
Est. completion date March 12, 2024

Study information
Verified date March 2024
Source Hospital Universitario San Ignacio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 12, 2024
Est. primary completion date March 12, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Continuous enteral nutrition infusion
Enteral nutrition administration in continuous infusion during 24 hours per day
• Cyclic enteral nutrition infusion
Enteral nutrition administration in continuous infusion during 16 hours per day

Locations
Country Name City State
Colombia Hospital Universitario San Ignacio Bogota Bogota DC

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario San Ignacio

Country where clinical trial is conducted

Colombia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Enteral nutrition delivered/Enteral nutrition prescribed x 100 Enteral nutrition delivered/Enteral nutrition prescribed x 100 24 hours
Secondary Enteral nutrition intolerance number of patients with intolerance/total number of patients 24 hours
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