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

November 2, 2019 updated by: Hasanuddin University

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 :

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia, 76124
        • Wahidin Sudirohusodo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 5% Dextrose
the parenteral formulation as prescribed by the intensive care specialist
Drug: 5% Dextrose
500 ml of 5% Dextrose administered to a peripheral vein.
Other Names:
  • D5
EXPERIMENTAL: High Protein Polymeric Formula

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
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
Other Names:
  • Peptisol
EXPERIMENTAL: Oligomeric Formula
Similar to the High Protein Polymeric Formula Procedure
Other: 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
Other Names:
  • Peptamen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days after intervention initiated

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sequential Organ Failure Assessment Score (SOFA) Score
Time Frame: Upon admission to Intensive Care Unit and 3 days after intervention
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
Acute Physiology, Age, Chronic Health Evaluation (APACHE) Score II
Time Frame: Upon admission to Intensive Care Unit and 3 days after intervention

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasanuddin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

March 31, 2018

Study Completion (ACTUAL)

July 7, 2018

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

November 2, 2019

First Posted (ACTUAL)

November 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 2, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3110191419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Critically Ill

Clinical Trials on 5% Dextrose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe