Bolus Versus Continuous Enteral Tube Feeding

Not Applicable

Completed

• Conditions: Major Abdominal Surgery; Sepsis; Trauma Injury
• Interventions: Diagnostic Test: Quadriceps Muscle Layer Fitness; Diagnostic Test: Muscle Strength; Diagnostic Test: Acute Physiology and Chronic Health Evaluation; Diagnostic Test: Sequential Organ Failure Assessment; Diagnostic Test: Nutritional Risk Screening; Diagnostic Test: Energy and Protein Intake

• Registration Number: NCT04080479
• Lead Sponsor: University Hospital Ostrava

Brief Summary

Stress metabolisms induced by severe trauma, large abdominal surgery procedures, sepsis, etc. leads to metabolic changes, which increase energy expenditure, enhanced protein catabolism, insulin resistance. Muscle proteolysis is massively stimulated. Critically ill patients pay for survival with a loss of muscles. Enteral nutrition, especially protein delivery to critically ill, is very important for optimizing their outcome. Standard enteral feeding regiments are generally based on continuous feeding, which is thought to be better tolerated by critically ill patients with easier glycaemic control by continuous infusion of insulin, translated in less glycaemic variability. But this approach is not physiological, continuous feeding does not allow protein synthesis. Optimal protein synthesis requires a pulsatile increase in branched-chain amino acids. Bolus feeding activates the entrohormonal axis (bioactive peptides, insulin), and stimulates skeletal muscle synthesis to the maximum extent. The question is, whether bolus enteral feeding in critically ill patients with limited gastrointestinal function delivers a greater amount of protein, improves nutritional parameters, with higher quadriceps muscle layer thickness (QMLT) and muscle strength.

Detailed Description

The trial has been designed in accordance with the Recommendations for Interventional Trials (SPIRIT 2013) and the Consolidated Standards for Reporting of Trials CONSORT guidelines.

Patients who meet the study inclusion criteria (severe trauma patients, surgical patients and medical patients with sepsis, with inserted nasogastric/nasoduodenal feed-ing tube) will be eligible to participate, especially patients who are mechanically ventilated. The last criterion is not a necessary precondition (a module of indirect calorimetry will be used in these patients). The necessary condition is the elimination of shock within 24 hours from the ICU admission and tolerance of trophic enteral feed-ing (20ml/hour) at for the period of at least 24 hours. Patients will be randomized in a ratio of 1:1 within 72 hours of their admission to receive bolus or continuous enteral feeding (sealed envelopes method). In both groups, the same goals of energy and protein will be observed (Day 1-2: E 15 kcal/kg/day, protein 0.8-1 g/kg/day; Day 3-4: E 20 kcal/kg/day, protein 1. 2 g/kg/day; Day ≥ 5: E 25 kcal/kg/day, protein 1.5-2 g/kg/day), according to protocol. The bolus enteral group will receive the amount of enteral nutrition in six boluses (per 60min dose), the continuous enteral group will receive the amount using a pump, within the timeframe of 6am-24pm. The need for parenteral nutrition will be determined by treating clinical staff independently to group allocation.

Demographic data collection: (weight, high, BMI) and conditions (trauma, surgical, medical patients), Acute Physiology and Chronic Health Evaluation (APACHE) Sequential Organ Failure Assessment (SOFA), Nutritional Risk Screening (NRS 2002).

Daily observations: glucose, mean glucose changes, insulin (IU/d), energy and protein intake (administered calories divided by the calculated energy expenditure and administered protein divided by calculated protein intake) - Adjusted/calculated energy and protein (%). Feeding intolerance (tolerating less than 40% of requirements via the enteral route for ≥ 3 days, diarrhea ≥ 500ml per day or five bowel actions). Mechanically ventilated patients (Resting Energy Expenditure (REE) and Respiratory Quotient (RQ) measured with indirect calorimetry) Day 1, 3, 5, 7: Nutritional parameters (serum albumin prealbumin, C-reactive protein (CRP), urine urea, N balance).

Day 1 and 7: Muscle layer thickness (QMLT by ultrasound measurement and mid-upper arm circumference) and muscle strength (dynamometer) from baseline to discharge. Outcomes of muscle strength/ultrasound and dynamometer) will be measured by an investigator blinded to the group allocation.

Study Timeline

• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Study Start: 2019-10-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• polytrauma
• major abdominal surgery
• sepsis
• ICU stay
• enteral feeding tube
• artificial ventilation

Exclusion Criteria

• contraindication of enteral feeding
• infaust prognosis
• prolonged shock (more than 24 hours)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bolus enteral feeding	Muscle Strength	The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake
Bolus enteral feeding	Acute Physiology and Chronic Health Evaluation	The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake
Bolus enteral feeding	Sequential Organ Failure Assessment	The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake
Bolus enteral feeding	Nutritional Risk Screening	The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake
Bolus enteral feeding	Energy and Protein Intake	The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake
Bolus enteral feeding	Quadriceps Muscle Layer Fitness	The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake
Continuous enteral feeding	Muscle Strength	The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake
Continuous enteral feeding	Quadriceps Muscle Layer Fitness	The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake
Continuous enteral feeding	Acute Physiology and Chronic Health Evaluation	The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake
Continuous enteral feeding	Nutritional Risk Screening	The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake
Continuous enteral feeding	Sequential Organ Failure Assessment	The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake
Continuous enteral feeding	Energy and Protein Intake	The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake

Primary Outcome Measures

Name	Time	Method
Change in inflammatory parameters - C-reactive protein (CRP)	7 days	The development of inflammatory parameters in mg/L will be observed.
Change in nutritional parameters - serum albumin	7 days	The development of the serum albumin levels in g/dL will be observed.
Change in nutritional parameters - prealbumin	7 days	The development of the serum albumin levels in mg/dL will be observed.
Change in muscle strength	7 days	The development of muscle strength (in kilograms) will be measured.
Change in muscle mass	7 days	The development of muscle mass (circumference in centimetres) will be measured.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia