NCT04080479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

2 years

First QC Date

September 3, 2019

Last Update Submit

December 6, 2022

Conditions

Trauma InjuryMajor Abdominal SurgerySepsis

Keywords

bolus enteral feedingcontinuous enteral feedingprotein synthesisnutritional parameters

Outcome Measures

Primary Outcomes (5)

  • Change in nutritional parameters - serum albumin

    The development of the serum albumin levels in g/dL will be observed.

    7 days

  • Change in nutritional parameters - prealbumin

    The development of the serum albumin levels in mg/dL will be observed.

    7 days

  • Change in inflammatory parameters - C-reactive protein (CRP)

    The development of inflammatory parameters in mg/L will be observed.

    7 days

  • Change in muscle mass

    The development of muscle mass (circumference in centimetres) will be measured.

    7 days

  • Change in muscle strength

    The development of muscle strength (in kilograms) will be measured.

    7 days

Study Arms (2)

Bolus enteral feeding

EXPERIMENTAL

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

Diagnostic Test: Quadriceps Muscle Layer FitnessDiagnostic Test: Muscle StrengthDiagnostic Test: Acute Physiology and Chronic Health EvaluationDiagnostic Test: Sequential Organ Failure AssessmentDiagnostic Test: Nutritional Risk ScreeningDiagnostic Test: Energy and Protein Intake

Continuous enteral feeding

EXPERIMENTAL

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

Diagnostic Test: Quadriceps Muscle Layer FitnessDiagnostic Test: Muscle StrengthDiagnostic Test: Acute Physiology and Chronic Health EvaluationDiagnostic Test: Sequential Organ Failure AssessmentDiagnostic Test: Nutritional Risk ScreeningDiagnostic Test: Energy and Protein Intake

Interventions

Quadriceps Muscle Layer FitnessDIAGNOSTIC_TEST

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

Also known as: QMLF
Bolus enteral feedingContinuous enteral feeding
Muscle StrengthDIAGNOSTIC_TEST

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

Bolus enteral feedingContinuous enteral feeding
Acute Physiology and Chronic Health EvaluationDIAGNOSTIC_TEST

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

Also known as: APACHE
Bolus enteral feedingContinuous enteral feeding
Sequential Organ Failure AssessmentDIAGNOSTIC_TEST

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

Also known as: SOFA
Bolus enteral feedingContinuous enteral feeding
Nutritional Risk ScreeningDIAGNOSTIC_TEST

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

Also known as: NSR
Bolus enteral feedingContinuous enteral feeding
Energy and Protein IntakeDIAGNOSTIC_TEST

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.

Bolus enteral feedingContinuous enteral feeding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (4)

  • Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.

    PMID: 23303884BACKGROUND

  • Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.

    PMID: 22019563BACKGROUND

  • Fetterplace K, Deane AM, Tierney A, Beach L, Knight LD, Rechnitzer T, Forsyth A, Mourtzakis M, Presneill J, MacIsaac C. Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial). Pilot Feasibility Stud. 2018 Feb 20;4:52. doi: 10.1186/s40814-018-0249-9. eCollection 2018.

    PMID: 29484196BACKGROUND

  • Tillquist M, Kutsogiannis DJ, Wischmeyer PE, Kummerlen C, Leung R, Stollery D, Karvellas CJ, Preiser JC, Bird N, Kozar R, Heyland DK. Bedside ultrasound is a practical and reliable measurement tool for assessing quadriceps muscle layer thickness. JPEN J Parenter Enteral Nutr. 2014 Sep;38(7):886-90. doi: 10.1177/0148607113501327. Epub 2013 Aug 26.

    PMID: 23980134BACKGROUND

MeSH Terms

Conditions

Accidental InjuriesSepsis

Interventions

Muscle Strength

Condition Hierarchy (Ancestors)

Wounds and InjuriesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marcela Káňová, MD,PhD

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking will be used in the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study subjects will be randomized into one of the two study arms.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 6, 2019

Study Start

October 1, 2019

Primary Completion

September 30, 2021

Study Completion

December 31, 2021

Last Updated

December 7, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available to other researchers.

Locations

CZ(1)