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

NCT04150978 | Completed

• 1 other identifier: 3110191419
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Critically Ill; Intensive Care Unit

Keywords

High Protein Polymeric Feeding; APACHE II Score; SOFA Score; NUTRIC Score; Critical Illness; Intensive Care Unit; Oligomeric Protein Feeding

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (2)

• Sequential Organ Failure Assessment Score (SOFA) Score

  Upon admission to Intensive Care Unit and 3 days after intervention

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

  Upon admission to Intensive Care Unit and 3 days after intervention

Study Arms (3)

5% Dextrose

ACTIVE COMPARATOR

the parenteral formulation as prescribed by the intensive care specialist

Drug: 5% Dextrose

High Protein Polymeric Formula

EXPERIMENTAL

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

Oligomeric Formula

EXPERIMENTAL

Similar to the High Protein Polymeric Formula Procedure

Other: Oligomeric Formula

Interventions

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

Also known as: Peptisol

High Protein Polymeric Formula

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

Also known as: Peptamen

Oligomeric Formula

5% Dextrose DRUG

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

Also known as: D5

5% Dextrose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- stable hemodynamic values

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Wahidin Sudirohusodo General Hospital

Makassar, South Sulawesi, 76124, Indonesia

Location

Related Publications (12)

• Berg A, Rooyackers O, Bellander BM, Wernerman J. Whole body protein kinetics during hypocaloric and normocaloric feeding in critically ill patients. Crit Care. 2013 Jul 24;17(4):R158. doi: 10.1186/cc12837.

  PMID: 23883571 BACKGROUND

• Biolo G, Tipton KD, Klein S, Wolfe RR. An abundant supply of amino acids enhances the metabolic effect of exercise on muscle protein. Am J Physiol. 1997 Jul;273(1 Pt 1):E122-9. doi: 10.1152/ajpendo.1997.273.1.E122.

  PMID: 9252488 BACKGROUND

• Biolo G, Grimble G, Preiser JC, Leverve X, Jolliet P, Planas M, Roth E, Wernerman J, Pichard C; European Society of Intensive Care Medicine Working Group on Nutrition and Metabolism. Position paper of the ESICM Working Group on Nutrition and Metabolism. Metabolic basis of nutrition in intensive care unit patients: ten critical questions. Intensive Care Med. 2002 Nov;28(11):1512-20. doi: 10.1007/s00134-002-1512-2. Epub 2002 Oct 1.

  PMID: 12415440 BACKGROUND

• Dungan KM, Braithwaite SS, Preiser JC. Stress hyperglycaemia. Lancet. 2009 May 23;373(9677):1798-807. doi: 10.1016/S0140-6736(09)60553-5.

  PMID: 19465235 BACKGROUND

• Higgins PA, Daly BJ, Lipson AR, Guo SE. Assessing nutritional status in chronically critically ill adult patients. Am J Crit Care. 2006 Mar;15(2):166-76; quiz 177.

  PMID: 16501136 BACKGROUND

• Kim H, Stotts NA, Froelicher ES, Engler MM, Porter C. Enteral nutritional intake in adult korean intensive care patients. Am J Crit Care. 2013 Mar;22(2):126-35. doi: 10.4037/ajcc2013629.

  PMID: 23455862 BACKGROUND

• Lena D, Kalfon P, Preiser JC, Ichai C. Glycemic control in the intensive care unit and during the postoperative period. Anesthesiology. 2011 Feb;114(2):438-44. doi: 10.1097/ALN.0b013e3182078843. No abstract available.

  PMID: 21245729 BACKGROUND

• Löfgren E, Md. 2015. Early enteral nutrition compared to outcome in critically ill trauma patients at a level one trauma centre. S Afr J Clin Nutr;28(2):70-76

  BACKGROUND

• Marik PE, Bellomo R. Stress hyperglycemia: an essential survival response! Crit Care. 2013 Mar 6;17(2):305. doi: 10.1186/cc12514.

  PMID: 23470218 BACKGROUND

• de Souza Menezes F, Leite HP, Koch Nogueira PC. Malnutrition as an independent predictor of clinical outcome in critically ill children. Nutrition. 2012 Mar;28(3):267-70. doi: 10.1016/j.nut.2011.05.015. Epub 2011 Aug 27.

  PMID: 21872433 BACKGROUND

• Mowery NT, Dortch MJ, Dossett LA, Norris PR, Diaz JJ Jr, Morris JA Jr, May AK. Insulin resistance despite tight glucose control is associated with mortality in critically ill surgical patients. J Intensive Care Med. 2009 Jul-Aug;24(4):242-51. doi: 10.1177/0885066609335663. Epub 2009 Jul 17.

  PMID: 19617231 BACKGROUND

• Soeters MR, Soeters PB. The evolutionary benefit of insulin resistance. Clin Nutr. 2012 Dec;31(6):1002-7. doi: 10.1016/j.clnu.2012.05.011. Epub 2012 Jun 7.

  PMID: 22682085 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Peptamen; Glucose

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Agussalim Bukhari, MD, Ph.D

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator is blinded from any information regarding the treatment allocation of participants during the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within 24-48 hours, Intensive care patients are allocated into three treatment, Enteral High-Protein Formulas, Oligomeric Formula, and 5% Dextrose Solution as control

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 5, 2019
• Study Start: October 1, 2017
• Primary Completion: March 31, 2018
• Study Completion: July 7, 2018
• Last Updated: November 5, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)