Protein Delivery in Intermittent and Continuous Enteral Nutrition in ICU Patients

NCT03587870 | Recruiting DMC

• 1 other identifier: EKNZ 2018-00259
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Acute skeletal muscle wasting in ICU patients is associated with functional impairment and with increased risk of death. Of what we know today, physical disability can persist up to 5 years. Adequate nutrition is the basis for an optimal recovery for ICU patients and for prevention of muscle wasting. Today, continuous feeding is still the standard enteral nutrition form for patients in the ICU to limit the incidence of aspiration. A study of Serpa et al. and Georgia et al. compared the continuous feeding versus a bolus nutrition with a feeding time of 30 - 60 minutes every 4 hours. They showed no statistical differences in complications between both groups. ProBoNo is a prospective, randomized, controlled pilot study of critically ill patients with a protein- rich formula to explore the impact of continuous or intermittent bolus nutrition on muscle breakdown in ICU patients. The investigators would like to recruit 68 patients during the first 24 hours after surgical intensive care unit admission. Prior beginning of nutrition administration, and on the 7th day thereafter the investigators will perform a muscle biopsy and an ultrasound from the vastus lateralis muscle in both groups. The primary outcome is the time from 6.00 am of the following day after admission until the patient reaches his daily protein's target quantity. Secondary outcomes include the diameter and densitiy of the hamstrings assessed by ultrasound and histology, the process of gastric residual volume, number of diarrhoea events and laboratory findings like glucose, urea and insulin like growth factor (IGF)-1, all compared between the two time points. Intermittent feeding is not only more natural and could help to limit the muscle wasting in ICU patients, it is also easier to handle for the ICU caring medical team. A trial from Georgia et al. in 2007 compared continuous to intermittent enteral nutrition. They found that the intermittently fed patients reached their nutrition goal faster than those being continuously nourished. This might in part be explained by feeding interruptions in the continuous feeding regimen. Presumably, preoperative holding of tube feedings in the continuous nutrition group most commonly caused interruptions. Thus, independently from prevention of muscle breakdown, a bolus nutrition would be more attractive.

Conditions

Muscle Wasting in Critically Ill

Keywords

intensive care unit; intermittent enteral nutrition; continuous enteral nutrition; muscle wasting

Outcome Measures

Primary Outcomes (1)

• Daily protein target quantity

  Is the time from 6.00 am of the following day after admission until the patient reaches his daily protein target quantity (1.2 g/ kg Biologische Wertigkeit (BW)/ biological value protein in the control group, to 1.5 g/kg BW protein in the experimental group).

  During ICU stay for the duration of 7 days after study inclusion

Secondary Outcomes (6)

• Diameter of the hamstrings

  During ICU stay, exactly 7 days after study inclusion

• Gastric residual content

  Every day during ICU stay for the duration of 7 days after study inclusion

• Diarrhoea

  Every day during ICU stay for the duration of 7 days after study inclusion

• Glucose (mmol/l) measurement

  Every day during ICU stay for the duration of 7 days after study inclusion

• BUN (mg/dl) measurement

  Every day during ICU stay for the duration of 7 days after study inclusion

Study Arms (2)

Bolus enteral nutrition with Fresubin Intensive

EXPERIMENTAL

Bolus nutrition over 30-40 minutes every 4 hours with Fresubin Intensive

Other: Enteral nutrition with Fresubin Intensive

Continuous enteral nutrition with Fresubin Intensive

ACTIVE COMPARATOR

Continuous nutrition over 20 hours per day with Fresubin Intensive (standard)

Other: Enteral nutrition with Fresubin Intensive

Interventions

Enteral nutrition with Fresubin Intensive OTHER

Comparison of intermittent (experimental) vs continuous (standard, active comparator) enteral nutrition on muscle wasting in critically ill patients

Bolus enteral nutrition with Fresubin Intensive; Continuous enteral nutrition with Fresubin Intensive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature
• Adult patients (age 18 years or older)
• Expected ICU stay of five days or longer
• Expected enteral feeding during at least five days

You may not qualify if:

• Pregnancy or breast feeding (women of childbearing age are tested for high beta-human chorionic gonadotropin (hCG) in urine or serum upon ICU admission)
• Clinically significant chronic or acute kidney insufficiency with a glomerular filtration rate (GFR) \<15.
• BMI ≤ 18 and ≥ 35.
• Intestinal perforation, peritonitis, intestinal fistula, necrosis or other contraindication to enteral diet
• Death or discharge before 48 hours of observation
• Noradrenaline ≥ 0.5 µg/kg bodyweight /min
• Inherited and chronic skeletal muscle disease (e.g. Morbus Duchenne or other motoneuron disease)
• Paralysis (e.g. hemiplegia, tetraplegia and paraplegia)
• Immunosuppression
• Haematologic malignancy

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, operative ICU

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

Related Publications (1)

• Reinhold S, Yeginsoy D, Hollinger A, Todorov A, Tintignac L, Sinnreich M, Kiss C, Gebhard CE, Kovacs B, Gysi B, Imwinkelried L, Siegemund M. Protein delivery in intermittent and continuous enteral nutrition with a protein-rich formula in critically ill patients-a protocol for the prospective randomized controlled proof-of-concept Protein Bolus Nutrition (Pro BoNo) study. Trials. 2020 Aug 25;21(1):740. doi: 10.1186/s13063-020-04635-1.

  PMID: 32843075 DERIVED

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Alexa Hollinger, MD

  University Hospital Basel, Basel Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexa Hollinger, MD

CONTACT

+41786747130; alexa.hollinger@usb.ch

Désirée Yeginsoy, MD

CONTACT

+41774261353; desi.y@bluewin.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, randomised controlled pilot study in critical ill patients with a protein-rich formula

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 16, 2018
• Study Start: March 25, 2019
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CH (1)