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

Hasanuddin University

Status: Completed

Conditions: Critically Ill; Intensive Care Unit

Treatments: Other: High Protein Polymeric Formula; Drug: 5% Dextrose; Other: Oligomeric Formula

Study type: Interventional

Funder types: Other

Identifiers

NCT04150978

3110191419

Details and patient eligibility

About

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

Full description

Procedure :

1. All patients admitted to the Intensive care unit will undergo eligibility screening

2. Baseline assessments will be performed to eligible participants upon the first 24 hours including :

   1. 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).
   2. 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)
   3. Scoring of Severity-of-illness using the laboratory parameters and clinical parameters under SOFA, APACHE II Score and NUTRIC score elements

3. The allocation of the participants is performed through simple randomization with the masking of the investigator.

4. the intervention will be done according to the protocol of each arm.

5. Measurement of outcomes according to the time frame by the intensive care and nutritionist team.

6. 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

5% Dextrose

Active Comparator group

Description:

the parenteral formulation as prescribed by the intensive care specialist

Treatment:

Drug: 5% Dextrose

High Protein Polymeric Formula

Experimental group

Description:

Procedure : 1. The daily calorie and protein prescriptions were calculated from standard recommendations (calories 25-30 kcal/kg/d, proteins 1.2-2 g/kg/d) 2. 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.

Treatment:

Other: High Protein Polymeric Formula

Oligomeric Formula

Experimental group

Description:

Similar to the High Protein Polymeric Formula Procedure

Treatment:

Other: Oligomeric Formula