NCT04580680 Extracorporeal Blood Purification Therapy in Critically Ill Patients (GlobalARRT)
| NCT ID | NCT04580680 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Careggi Hospital |
| Condition | Critical Illness |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2020-11-01 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2020-11-01 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Worldwide, the use of Extracorporeal Blood Purification (EBP) in everyday clinical practice is becoming increasingly common, particularly in critical care settings. The efficacy of most of these treatments on removal of inflammatory mediators is the main rationale behind the use of EBP in critically ill patients with multiorgan dysfunction. Nonetheless, there are still some doubts as to the clinical efficacy of bacterial toxins and cytokines removal and many clinical trials aiming at exploring the effect of EBP on long-term outcomes of septic patients have failed to demonstrate consistent results regarding 28 day- or hospital-mortality rates. The primary aim of this observational prospective web-based registry is to define the possible clusters of critically ill patients - treated with extracorporeal blood purification therapies worldwide - who are homogeneous regarding both clinical and treatment characteristics and seem to benefit the most from EBP.
Eligibility Criteria
Inclusion Criteria: patients who meet all the following inclusion criteria may be included in this study: 1. Admission to ICU 2. Indications for at least one of the following extracorporeal blood purification treatments: 1. Continuous Renal Replacement Therapy (CRRT) / Intermittent Hemodialysis (IHD) / Hybrid therapies for renal support/replacement; 2. Immunomodulation therapy in critically ill patients using hemodiafilters with larger pore sizes characterized by enhanced transmembrane clearance of larger molecules (such as cytokines), hemodiafilters with enhanced unselective absorption of cytokines and/or endotoxins, cartridges with enhanced absorption of cytokines and/or endotoxins, techniques aimed at improving extracorporeal removal of cytokines and/or endotoxins. It should be underlined that the lack of established guidelines on the use of membranes for extracorporeal blood purification (and on RRTs in general) leads to variability in clinical practice and treatments are initiated in accordance with the judgement of the responsible physician. Under these circumstances, it is preferable to keep inclusion criteria as wide as possible so as to obtain a real picture of clinical practice worldwide. Exclusion Criteria: besides contraindications to the use of the EBP adopted (as from the manual of instructions), there are no exclusion criteria.
Contact & Investigator
Gianluca Villa, md
PRINCIPAL INVESTIGATOR
University of Florence, Florence, Italy
Frequently Asked Questions
Who can join the NCT04580680 clinical trial?
This trial is open to participants of all sexes, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04580680 currently recruiting?
Yes, NCT04580680 is actively recruiting participants. Contact the research team at gianluca.villa@unifi.it for enrollment information.
Where is the NCT04580680 trial being conducted?
This trial is being conducted at Florence, Italy.
Who is sponsoring the NCT04580680 clinical trial?
NCT04580680 is sponsored by Careggi Hospital. The principal investigator is Gianluca Villa, md at University of Florence, Florence, Italy. The trial plans to enroll 1,000 participants.