Status:
WITHDRAWN
The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial
Lead Sponsor:
RWTH Aachen University
Collaborating Sponsors:
Clinical Evaluation Research Unit at Kingston General Hospital
Conditions:
Nutritional Disorder
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary research question: In critically ill patients with nutrition 'risk factors', what is the effect of providing combined EN/PN to the group prescribed a higher dose (≥2.2 grams/kg/day) of pro...
Detailed Description
Positive, neutral, or negative, the results of the EFFORTcombo study will inform the clinical practice in ICU settings around the world. If positive, because of the pragmatic, multicentre nature of th...
Eligibility Criteria
Inclusion
- ≥18 years old;
- Expected to remain mechanically ventilated for an additional 48 hours from screening;
- And have one or more of the following risk factors that make them at high nutritional risk:
- Low (≤25) or High BMI (≥35)
- Moderate to severe malnutrition (as defined by local assessments). We will document the means by which sites are making this determination and capture the elements of the assessment (history of weight loss, history of reduced oral intake, etc.).
- Frailty (Clinical Frailty Scale 5 or more from proxy)
- Sarcopenia (SARC-F score of 4 or more from proxy)
- From point of screening, projected duration of mechanical ventilation \>4 days
Exclusion
- \>96 continuous hours of mechanical ventilation before enrollment
- Expected death or withdrawal of life-sustaining treatments within 7 days from screening
- Pregnancy
- The responsible clinician feels that the patient either needs low or high protein
- Absolute contraindication to EN
- Severe metabolic disorders including electrolyte disorders, uncontrolled hyperglycemia, hyperlipidemia, hypophosphatemia.
- Severe chronic liver disease (MELD-score \>20) or acute fulminant hepatitis.
- Metabolic disorders involving impaired nitrogen utilization
- Not ambulating independently prior to illness that lead to ICU admission (use of gait aid permitted)
- Lower extremity injury or impairments that prevents them walking prior to hospital discharge (e.g. amputation, knee/hip injury)
- Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
- Pre-existing primary severe systemic neuromuscular disease resulting in severe weakness pre-ICU (e.g., Guillain Barre)
- Intracranial or spinal process affecting motor function
- Patients in hospital \>5 days prior to ICU admission
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04012333
Start Date
June 1 2020
End Date
March 1 2022
Last Update
October 27 2022
Active Locations (1)
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1
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, Germany, 52074