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

Critically Ill Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150978
• Other study ID #: 3110191419
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: July 7, 2018

Study information

• Verified date: November 2019
• Source: Hasanuddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 7, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Intensive Care Unit
• Malnutrition

Intervention

Other:
• High Protein Polymeric 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
• Oligomeric Formula
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

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

Locations

Country	Name	City	State
Indonesia	Wahidin Sudirohusodo General Hospital	Makassar	South Sulawesi

Sponsors (1)

Lead Sponsor	Collaborator
Hasanuddin University

Country where clinical trial is conducted

Indonesia, 

References & 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. — View 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. Epub 2002 Oct 1. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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

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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Upon admission to Intensive Care Unit and 3 days after intervention
Other	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	Upon admission to Intensive Care Unit and 3 days after intervention
Primary	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