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NCT Number: NCT04150978

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

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

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Intensive Care Unit Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wahidin Sudirohusodo General Hospital

Makassar, South Sulawesi, 76124, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Protein Polymeric Formula

Other

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

Other names: Peptisol

Oligomeric Formula

Other

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

Other names: Peptamen

5% Dextrose

Drug

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

Other names: D5

Primary outcomes

  1. Nutrition Risk in the Critically Ill (NUTRIC) Score

    Time frame: 3 days after intervention initiated

    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.

Other outcomes

  1. Sequential Organ Failure Assessment Score (SOFA) Score

    Time frame: Upon admission to Intensive Care Unit and 3 days after intervention

    The sequential organ failure assessment score (SOFA score) is a clinical scoring to determine the extent of a person's organ function or rate of failure during a stay in an intensive care unit (ICU) including the assessment of respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. The elements including PaO2/FiO2 (mmHg), Glasgow Coma Scale, Mean arterial pressure OR administration of vasopressors required, Bilirubin Level, Platelets, and Creatinine (mg/dl) [μmol/L] (or urine output). Each domain has scale from 0-4, with a total score for all domains is 24. Higher number indicates severe organ failure.

  2. Acute Physiology, Age, Chronic Health Evaluation (APACHE) Score II

    Time frame: Upon admission to Intensive Care Unit and 3 days after intervention

    Acute Physiology, Age, Chronic Health Evaluation (APACHE) Score II is an ICU-scoring system to measure the risk and severity of the disease, including :

    AaDO2 or PaO2 (depending on FiO2) Temperature (rectal) Mean arterial pressure pH arterial Heart rate Respiratory rate Sodium (serum) Potassium (serum) Creatinine Hematocrit White blood cell count Glasgow Coma Scale. An integer score from 0 to 71 is computed based on measurements above; higher scores correspond to more severe disease and a higher risk of death

Sponsors and collaborators

Lead sponsor

Hasanuddin University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 5, 2019
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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