Last reviewed · How we verify
NCT05918757: FISIO
Efficacy and Safety of Administration of High Levels of Protein to Critically Ill Patients.
NA trial testing Protein dose 1.5 g/kg/day in Intensive Care Unit Acquired Weakness in 200 participants. Participants enrolled and being followed up; not accepting new ones.
31 March 2024
Quick facts
| Lead sponsor | Spanish Society of Critical Care Medicine and Coronary Units |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 200 |
| Start date | 1 January 2022 |
| Primary completion | 31 March 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 18 locations across Spain |
Drugs / interventions tested
- Protein dose 1.5 g/kg/day
- Protein dose 1.0 g/kg/day
Conditions studied
- Intensive Care Unit Acquired Weakness — all drugs for Intensive Care Unit Acquired Weakness →
Sponsor
Spanish Society of Critical Care Medicine and Coronary Units
Who can join
18 and older, any sex, with Intensive Care Unit Acquired Weakness. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05918757
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT04989790 — Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05918757 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Spanish Society of Critical Care Medicine and Coronary Units
- Last refreshed: 20 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05918757.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing