Comparing protein delivery methods in ICU patients
Protein Delivery in Intermittent and Continuous Enteral Nutrition in ICU Patients A Prospective, Randomised Controlled Pilot Study in Critical Ill Patients With a Protein-rich Formula
This study is testing if giving protein through intermittent feeding instead of continuous feeding can help critically ill patients in the ICU keep their muscles and recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel, Canton of Basel-City) |
| Trial ID | NCT03587870 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of continuous versus intermittent enteral nutrition on muscle wasting in critically ill patients. It aims to recruit 68 adult patients within the first 24 hours of their ICU admission and will utilize a protein-rich formula for enteral feeding. The study will assess whether intermittent bolus feeding can be as effective as continuous feeding in preventing muscle breakdown and improving recovery outcomes. The research is designed as a prospective, randomized, controlled pilot study to provide insights into optimal nutritional strategies in the ICU setting.
Who should consider this trial
Good fit: Ideal candidates are adult ICU patients expected to require enteral feeding for at least five days.
Not a fit: Patients with significant chronic or acute kidney insufficiency, severe obesity or underweight, or those with contraindications to enteral feeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved nutritional strategies that enhance recovery and reduce muscle wasting in critically ill patients.
How similar studies have performed: Previous studies have shown no significant differences in complications between continuous and intermittent feeding, suggesting that this approach may yield valuable insights into nutritional practices in the ICU.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Basel, Canton of Basel-City
- University Hospital Basel, operative ICU — Basel, Canton of Basel-City, Switzerland (Recruiting)
Study contacts
- Principal investigator: Alexa Hollinger, MD — University Hospital Basel, Basel Switzerland
- Study coordinator: Alexa Hollinger, MD
- Email: alexa.hollinger@usb.ch
- Phone: +41786747130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.