Clinical trial NCT04150978: High Protein Formula on Enteral Feeding in Clinical Improvement and Malnutrition at Intensive Care Unit Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Nutrition Risk in the Critically Ill (NUTRIC) Score
timeFrame: 3 days after intervention initiated
Secondary outcomes:
Other outcomes:
measure: Sequential Organ Failure Assessment Score (SOFA) Score
timeFrame: Upon admission to Intensive Care Unit and 3 days after intervention
measure: Acute Physiology, Age, Chronic Health Evaluation (APACHE) Score II
timeFrame: Upon admission to Intensive Care Unit and 3 days after intervention
Locations:
city: Makassar
country: Indonesia
facility: Wahidin Sudirohusodo General Hospital
state: South Sulawesi
Study officials:
affiliation: Hasanuddin University
name: Agussalim Bukhari, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Dungan KM, Braithwaite SS, Preiser JC. Stress hyperglycaemia. Lancet. 2009 May 23;373(9677):1798-807. doi: 10.1016/S0140-6736(09)60553-5.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: Marik PE, Bellomo R. Stress hyperglycemia: an essential survival response! Crit Care. 2013 Mar 6;17(2):305. doi: 10.1186/cc12514.
citation: 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.
citation: 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.
citation: 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.