Efficacy and Safety of Administration of High Levels of Protein to Critically Ill Patients. (NCT05918757) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Efficacy and Safety of Administration of High Levels of Protein to Critically Ill Patients.
Spain200 participantsStarted 2022-01-01
Plain-language summary
Critically ill patients are known to develop serious nutritional deterioration during the course of their disease. They develop, from the beginning, a multifactorial protein malnutrition that relates to a poor clinical course and the development of weakness. Due to the increased protein catabolism in this type of patient, there is a rapid degradation of muscle mass and loss of functional proteins, and therefore nutritional support is mandatory. Indeed, achieving a high protein intake may promote a better evolution of the critically ill patient, i.e., maintenance of muscle protein, less deterioration of muscle strength, lower Intensive care unit-acquired weakness (ICUAW), lower mortality, decrease in the number of infections, decrease in days on mechanical ventilation, and days of hospital stay and in ICU.
The goal of this clinical trial is to compare the appearance and degree of ICUAW in critically ill patients receiving invasive mechanical ventilation treated with two different doses of protein (1.5 g/kg/day vs.1.0 g/kg/day).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Critically ill patient
* ICU admission during the previous 48h
* Patients on expected invasive mechanical ventilation for three days
* Patients with a minimum expected duration of clinical nutrition of at least seven days
* Written informed consent signed by the patient or the patient's legally authorized representative.
* Available central venous access for continuous infusion of the study drugs.
Exclusion Criteria:
* Denied informed consent
* Acute renal failure (renal injury stage 3)
* Liver failure (cirrhosis or Child-Pugh Scale \> 5)
* Severe liver failure with International Normalized Ratio (INR) \> 1.7 (prothrombin time \> 50%) and encephalopathy
* Patients with COVID-19-derived pneumonia
* Body Mass Index (BMI) \> 40 or \< 18.5 (morbid obesity or previous caloric malnutrition)
* Pregnant patients
* Central Nervous System pathologies (Glasgow \< 6)
* Peripheral Nervous System pathologies interfering with study evaluations
* Patients with cognitive dysfunction/dementia or unable to follow instructions regarding MRC tests
* Severe muscular pathology
* Already participating in another clinical trial
* Impossibility to contact after ICU discharge to carry out the follow-up visit on day 90
* Known hypersensitivity to milk protein or any of the components of the nutritional supplement
* Inborn errors in the amino acid metabolism
* Previous inclusion in the present study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of intensive care unit acquired weakness (ICUAW).
Timeframe: Baseline, weekly in ICU up to 28 days after mechanical ventilation termination, throughout hospital stay, an expected average of 6 weeks, and 90 days after hospital discharge.
Trial details
NCT IDNCT05918757
SponsorSpanish Society of Critical Care Medicine and Coronary Units