Bolus Versus Continuous Enteral Tube Feeding

NCT04080479 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-12-07

No results posted yet for this study

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.

Conditions

  • Trauma Injury
  • Major Abdominal Surgery
  • Sepsis

Interventions

DIAGNOSTIC_TEST

Quadriceps Muscle Layer Fitness

The QMLF examination will be performed in all study subjects, with both bolus and continuous enteral feeding.

DIAGNOSTIC_TEST

Muscle Strength

All study subjects, with both bolus and continuous enteral feeding, will undergo measurement of the muscle strength using dynamometer.

DIAGNOSTIC_TEST

Acute Physiology and Chronic Health Evaluation

All study subjects, with both bolus and continuous enteral feeding, will undergo the APACHE evaluation.

DIAGNOSTIC_TEST

Sequential Organ Failure Assessment

All study subjects, with both bolus and continuous enteral feeding, will undergo the SOFA assessment.

DIAGNOSTIC_TEST

Nutritional Risk Screening

All study subjects, with both bolus and continuous enteral feeding, will undergo the NSR screening.

DIAGNOSTIC_TEST

Energy and Protein Intake

The amount of energy and protein supplied to the study subjects will be observed daily in all study subjects, with both bolus and continuous enteral feeding, the percentage of the planned daily intake will be analyzed.

Sponsors & Collaborators

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • Marcela Káňová, MD,PhD · University Hospital Ostrava

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-09-30
Completion
2021-12-31

Countries

  • Czechia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080479 on ClinicalTrials.gov