High Protein Formula on Enteral Feeding in Clinical Improvement and Malnutrition at Intensive Care Unit Patients

Study Overview
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Brief Summary
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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

Detailed Description
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Procedure : All patients admitted to the Intensive care unit will undergo eligibility screening Baseline assessments will be performed to eligible participants upon the first 24 hours including : anthropometric data (age, gender, height (participant in the supine position), ideal body weight (IBW), Mid-Upper-Arm Circumference (MUAC), and primary admission diagnosis (Traumatic Brain Injury/TBI or non-TBI). Laboratory assessment including platelets, white blood cells, lymphocytes, serum creatinine levels, blood urea nitrogen (BUN) levels, albumin, serum potassium levels, serum sodium levels, serum pH, the partial pressure of carbon dioxide, and partial pressure of oxygen (PO2) Scoring of Severity-of-illness using the laboratory parameters and clinical parameters under SOFA, APACHE II Score and NUTRIC score elements The allocation of the participants is performed through simple randomization with the masking of the investigator. the intervention will be done according to the protocol of each arm. Measurement of outcomes according to the time frame by the intensive care and nutritionist team. Data analysis including descriptive statistics and outcome analysis using paired t-test or Wilcoxon signed-rank test. Differences in mean values between the 3 groups are compared using the ANOVA or Kruskal-Wallis test. A p-value <0.05 is considered statistically significant.

Official Title
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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

Conditions
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Critically Ill, Intensive Care Unit

Intervention / Treatment
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* Other: High Protein Polymeric Formula
* Other: Oligomeric Formula
* Drug: 5% Dextrose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - stable hemodynamic values Exclusion Criteria: gastrointestinal resection contraindications for enteral feeding history of diabetes or chronic kidney disease given parenteral nutrition had severe intolerance for enteral nutrition or formula gastric residual volume > 250 ml/4 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Within 24-48 hours, Intensive care patients are allocated into three treatment, Enteral High-Protein Formulas, Oligomeric Formula, and 5% Dextrose Solution as control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5% Dextrose<br>the parenteral formulation as prescribed by the intensive care specialist | Drug: 5% Dextrose<br>* 500 ml of 5% Dextrose administered to a peripheral vein.<br>* Other names: D5;|
| Experimental: High Protein Polymeric Formula<br>Procedure : The daily calorie and protein prescriptions were calculated from standard recommendations (calories 25-30 kcal/kg/d, proteins 1.2-2 g/kg/d) Administered as boluses via a nasogastric tube. A total of 5 aliquots were administered at 4-hourly intervals in a daily feeding period of 24 hours, with the participant positioned 30° head-up. | Other: High Protein Polymeric Formula<br>* 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<br>* Other names: Peptisol;|
| Experimental: Oligomeric Formula<br>Similar to the High Protein Polymeric Formula Procedure | Other: Oligomeric Formula<br>* 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<br>* Other names: Peptamen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrition Risk in the Critically Ill (NUTRIC) Score | The Nutrition Risk in the Critically Ill (NUTRIC) Score is designed to quantify the risk of critically ill patients developing adverse events that may be modified by aggressive nutrition therapy ranging from 1-10. A score between 0-5 indicates a low malnutrition risk and 6 above means the patient is associated with worse clinical outcomes (mortality, ventilation) and the most likely to benefit from aggressive nutrition therapy. | 3 days after intervention initiated | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Protein Polymeric Feeding, APACHE II Score, SOFA Score, NUTRIC Score, Critical Illness, Intensive Care Unit, Oligomeric Protein Feeding