Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT03587870

Protein Delivery in Intermittent and Continuous Enteral Nutrition in ICU Patients

Led by University Hospital, Basel, Switzerland · Updated on 2025-11-18

68

Participants Needed

1

Research Sites

366 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Protein Delivery in Intermittent and Continuous Enteral Nutrition in ICU Patients

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Adult patients aged 18 years or older
  • Expected ICU stay of five days or longer
  • Expected to receive enteral feeding for at least five days
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Clinically significant kidney failure with glomerular filtration rate below 15
  • Body mass index (BMI) less than or equal to 18 or greater than or equal to 35
  • Intestinal conditions preventing enteral feeding such as perforation, peritonitis, fistula, or necrosis
  • Death or discharge before 48 hours of observation
  • High dose noradrenaline use (greater than or equal to 0.5 micrograms per kg per minute)
  • Inherited or chronic skeletal muscle diseases (e.g., Duchenne muscular dystrophy, motor neuron disease)
  • Paralysis including hemiplegia, tetraplegia, or paraplegia
  • Immunosuppression
  • Blood cancers

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Basel, operative ICU

Basel, Canton of Basel-City, Switzerland, 4031

Actively Recruiting

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Research Team

A

Alexa Hollinger, MD

CONTACT

D

Désirée Yeginsoy, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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