CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
5% Dextrose +2 moredrug
Likely dose
5% Dextrose 500 mlfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04150978
NCT04150978N/ACompleted

Effectiveness of Early Enteral Feeding With High Protein Formulas Versus Oligomeric Formula Versus 5% Dextrose Solution in Clinical Improvement and Malnutrition Prevention of Intensive Care Unit Patients. A Quasi-Experimental Design

Hasanuddin University·interventional·Posted Nov 5, 2019·Updated Nov 5, 2019

In Brief

A clinical study evaluating High Protein Polymeric Formula, Oligomeric Formula, and 1 other intervention for Critically Ill and Intensive Care Unit. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Effectiveness of Early Enteral Feeding With High Protein Polymeric Formula Versus Oligomeric Formula Versus 5% Dextrose Solution in Clinical Improvement and Malnutrition on Intensive Care Unit Patients Background : Critically ill patients are physiologically unstable, often have complex hypermetabolic responses to trauma. These patients are facing a high risk of death, multi-organ failure, and prolonged ventilator use. Nutrition is one of therapy for critical illness, however, patients often experience malnutrition caused by disease severity, delays in feeding, and miscalculation of calorie needs, therefore, appropriate management of enteral feeding formula should be done in preventing malnutrition and improve clinical outcome during intensive treatment. Objective: This study aims to evaluate clinical improvement and malnutrition in critically ill participants under two different early enteral feeding formulas versus parenteral feeding Methodology : A three-arm randomized trial is performed (parenteral (5% Dextrose), and enteral high-protein polymeric formula, and oligomeric formula.) at the Intensive Care Unit in Wahidin Sudirohusodo Hospital, Makassar, Indonesia. The enteral feedings are given through a nasogastric tube within 24-48 hours after intensive care unit (ICU) admission as well as the parenteral group. A meticulous record of the calories and protein of intake is maintained for 3 days follow up including clinical parameters. The changes between pre and post-intervention of clinical parameters and nutrition scoring are assessed as the outcome of the intervention Hypothesis : Enteral feeding with High Protein Formula provides a better clinical outcome and less malnutrition event in comparison to 5% Dextrose and Oligomeric Formula

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndonesia
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 5, 2019
Enrollment StartOct 1, 2017
Primary CompletionMar 31, 2018
Study CompletionJul 7, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.7 years ago

Interventions

High Protein Polymeric Formulaother

Component: 22.4% protein from total calorie Preparation of Peptisol: 5 spoons of Peptisol powder diluted in 200 ml warm water to have 250 ml Peptisol (equal to 250 kcal). Given as written in the group descriptions

Oligomeric Formulaother

Component: Component: 22.4% protein from total calorie Preparation: 5 spoons of Peptamen powder diluted in 165 ml warm water to have 200 ml Peptamen (equal to 200 kcal). Given as written in the group descriptions

5% Dextrosedrug

500 ml of 5% Dextrose administered to a peripheral vein.