Critically IllNCT04150978
High Protein Formula on Enteral Feeding in Clinical Improvement and Malnutrition at Intensive Care Unit Patients
A study testing High Protein Polymeric Formula, Oligomeric Formula and 5% Dextrose in people with Critically Ill and Intensive Care Unit, run by Hasanuddin University at 1 site in Indonesia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Intensive Care Unit
- What is being tested?
- High Protein Polymeric Formula, Oligomeric Formula and 5% Dextrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2017to 7 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable hemodynamic values
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Wahidin Sudirohusodo General Hospital
Makassar, South Sulawesi, 76124
About this study
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
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 :
Read more
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
Read the detailed description
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.
- Conditions
- Critically Ill, Intensive Care Unit
- Being tested
- High Protein Polymeric Formula, Oligomeric Formula, 5% Dextrose
- Keywords
- High Protein Polymeric Feeding, APACHE II Score, SOFA Score, NUTRIC Score, Critical Illness, Intensive Care Unit, Oligomeric Protein Feeding
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein Polymeric FormulaOther
Also called Peptisol
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 FormulaOther
Also called Peptamen
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
5% DextroseDrug
Also called D5
500 ml of 5% Dextrose administered to a peripheral vein.
| Study group | Role | What they receive |
|---|---|---|
| 5% Dextrose | Active comparator | the parenteral formulation as prescribed by the intensive care specialist Receives: 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. Receives: Other: High Protein Polymeric Formula |
| Oligomeric Formula | Experimental | Similar to the High Protein Polymeric Formula Procedure Receives: Other: Oligomeric Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days after intervention initiated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Oct 2017
- Primary completion31 Mar 2018
- Study completion7 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agussalim Bukhari, MD, Ph.D, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150978
- Sponsor's protocol ID
- 3110191419
- Status last verified
- Nov 2019
- First submitted
- 31 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23883571Biolo 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.
PubMed 9252488Biolo 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.
PubMed 12415440Dungan KM, Braithwaite SS, Preiser JC. Stress hyperglycaemia. Lancet. 2009 May 23;373(9677):1798-807. doi: 10.1016/S0140-6736(09)60553-5.
PubMed 19465235Higgins 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.
PubMed 16501136Kim 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.
PubMed 23455862Lena 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.
PubMed 21245729Löfgren 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.
PubMed 23470218de 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.
PubMed 21872433Mowery 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.
PubMed 19617231Soeters 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.
PubMed 22682085
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04150978
- Acronym / sponsor ID
- 3110191419
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 7 Jul 2018 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| 5% Dextrose | Active comparator | Drug: 5% Dextrosethe parenteral formulation as prescribed by the intensive care specialist |
| High Protein Polymeric Formula | Experimental | Other: High Protein Polymeric FormulaProcedure : 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. |
| Oligomeric Formula | Experimental | Other: Oligomeric FormulaSimilar to the High Protein Polymeric Formula Procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stable hemodynamic values
Key exclusion criteria (6 listed)
- gastrointestinal resection
- contraindications for enteral feeding
- history of diabetes or chronic kidney disease
- given parenteral nutrition
- had severe intolerance for enteral nutrition or formula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Protein Polymeric FormulaAlso: PeptisolComponent: 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 | High Protein Polymeric Formula |
| Oligomeric FormulaAlso: PeptamenComponent: 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 | Oligomeric Formula |
| 5% DextroseAlso: D5500 ml of 5% Dextrose administered to a peripheral vein. | Drug | 5% Dextrose |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Background: PubMed 23883571Berg 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.
- Background: PubMed 9252488Biolo 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.
- Background: PubMed 12415440Biolo 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.
- Background: PubMed 19465235Dungan KM, Braithwaite SS, Preiser JC. Stress hyperglycaemia. Lancet. 2009 May 23;373(9677):1798-807. doi: 10.1016/S0140-6736(09)60553-5.
- Background: PubMed 16501136Higgins 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.
- Background: PubMed 23455862Kim 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.
- Background: PubMed 21245729Lena 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.
- BackgroundLöfgren 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: PubMed 23470218Marik PE, Bellomo R. Stress hyperglycemia: an essential survival response! Crit Care. 2013 Mar 6;17(2):305. doi: 10.1186/cc12514.
- Background: PubMed 21872433de 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.
- Background: PubMed 19617231Mowery 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.
- Background: PubMed 22682085Soeters 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agussalim Bukhari, MD, Ph.D principal investigator
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein Polymeric Formula, Oligomeric Formula and 5% Dextrose in people with Critically Ill and Intensive Care Unit, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition Risk in the Critically Ill (NUTRIC) Score (time frame: 3 days after intervention initiated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04150978, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.