- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04080479
Bolus Versus Continuous Enteral Tube Feeding
Bolus Versus Continuous Enteral Feeding in Critically Ill Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Moravian-Silesian Region
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Ostrava, Moravian-Silesian Region, Czechia, 70852
- University Hospital Ostrava
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bolus enteral feeding
The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions:
|
The QMLF examination will be performed in all study subjects, with both bolus and continuous enteral feeding.
Other Names:
All study subjects, with both bolus and continuous enteral feeding, will undergo measurement of the muscle strength using dynamometer.
All study subjects, with both bolus and continuous enteral feeding, will undergo the APACHE evaluation.
Other Names:
All study subjects, with both bolus and continuous enteral feeding, will undergo the SOFA assessment.
Other Names:
All study subjects, with both bolus and continuous enteral feeding, will undergo the NSR screening.
Other Names:
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.
|
Experimental: Continuous enteral feeding
The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions:
|
The QMLF examination will be performed in all study subjects, with both bolus and continuous enteral feeding.
Other Names:
All study subjects, with both bolus and continuous enteral feeding, will undergo measurement of the muscle strength using dynamometer.
All study subjects, with both bolus and continuous enteral feeding, will undergo the APACHE evaluation.
Other Names:
All study subjects, with both bolus and continuous enteral feeding, will undergo the SOFA assessment.
Other Names:
All study subjects, with both bolus and continuous enteral feeding, will undergo the NSR screening.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in nutritional parameters - serum albumin
Time Frame: 7 days
|
The development of the serum albumin levels in g/dL will be observed.
|
7 days
|
Change in nutritional parameters - prealbumin
Time Frame: 7 days
|
The development of the serum albumin levels in mg/dL will be observed.
|
7 days
|
Change in inflammatory parameters - C-reactive protein (CRP)
Time Frame: 7 days
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The development of inflammatory parameters in mg/L will be observed.
|
7 days
|
Change in muscle mass
Time Frame: 7 days
|
The development of muscle mass (circumference in centimetres) will be measured.
|
7 days
|
Change in muscle strength
Time Frame: 7 days
|
The development of muscle strength (in kilograms) will be measured.
|
7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcela Káňová, MD,PhD, University Hospital Ostrava
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FNO-KARIM-12-Enteral_Feeding
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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