An interventional study of High Protein Polymeric Formula and Oligomeric Formula in Critically Ill and Intensive Care Unit, sponsored by Hasanuddin University. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-05.
Sponsored by Hasanuddin University · Not applicable, Interventional, and Treatment
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
Procedure :
Baseline assessments will be performed to eligible participants upon the first 24 hours including :
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.
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Exclusion Criteria:
the parenteral formulation as prescribed by the intensive care specialist
Drug: 5% Dextrose
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.
Other: High Protein Polymeric Formula
Similar to the High Protein Polymeric Formula Procedure
Other: Oligomeric Formula
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
Also known as: Peptisol
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
Also known as: Peptamen
500 ml of 5% Dextrose administered to a peripheral vein.
Also known as: D5
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.
Time frame: 3 days after intervention initiated
Sequential Organ Failure Assessment Score (SOFA) Score
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.
Time frame: Upon admission to Intensive Care Unit and 3 days after intervention
Acute Physiology, Age, Chronic Health Evaluation (APACHE) Score II
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
Time frame: Upon admission to Intensive Care Unit and 3 days after intervention
Plan to share: No
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Hasanuddin University