Actively Recruiting
The Effect of Filter Lifespan in Continuous Renal Replacement Therapy on the Rate of New Infections in Critically Ill Patients: a Prospective, Multicenter, Observational Trial
Led by University Hospital Muenster · Updated on 2024-12-12
600
Participants Needed
5
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University Hospital Muenster
Lead Sponsor
B
Baxter Healthcare Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Approximately half of the patients in intensive care units (ICU) experience acute kidney injury (AKI), which complicates their treatment. Continuous renal replacement therapy (CRRT) is commonly used to support kidney function in these critically ill patients, as it allows continuous and controlled fluid removal and is better tolerated than intermittent dialysis. However, the use of CRRT involves intravascular access and artificial circuits that may increase infection risk. This observational trial aims to study factors influencing new infections in critically ill patients receiving CRRT, focusing on the impact of filter lifespan. This study observes critically ill patients undergoing continuous renal replacement therapy without altering their treatment, which is directed by their ICU physicians. There are no specific interventions assigned by the study, as it is purely observational. Researchers will monitor patients from the start of dialysis for up to 28 days or until the end of CRRT, collecting data on infections, filter lifespan, and other clinical events. Participants will be closely evaluated through various assessments during their ICU stay, including tracking new infections such as bloodstream infections, pneumonia, urinary tract infections, and catheter-related infections. Additional data on dialysis downtime, duration of mechanical ventilation, bleeding complications, kidney function recovery, and mortality will be collected up to 90 days after dialysis starts. The trial will analyze these outcomes to better understand infection risks and patient recovery in this vulnerable population.
CONDITIONS
Brief Title
Filter Lifespan in Continuous Renal Replacement Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Critically ill patients with dialysis-dependent acute kidney injury
- Receiving continuous renal replacement therapy (CRRT)
- Able to provide written informed consent
You will not qualify if you...
- Chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2
- Chronic dialysis dependency
- History of kidney transplant
- Diagnosed (glomerulo-)nephritis, interstitial nephritis, or vasculitis
- Currently on immunosuppressive therapy
- Chronic inflammatory diseases such as arthritis, HIV, or chronic hepatitis
- Employment by or dependency on the investigator or sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days from start of dialysis
Participants who undergo routine continuous renal replacement therapy (CRRT) are observed to investigate the factors influencing new onset infections and other outcomes during CRRT.
Daily assessments during CRRT up to 28 days
Duration - Up to 90 days after start of dialysis
Participants are followed up to assess kidney function recovery, need for kidney replacement therapy, and mortality at 28, 60, and 90 days after start of dialysis.
Assessments at day 28, day 60, and day 90
Trial Site Locations
Total: 5 locations
1
Univ.-Klinik Innsbruck
Innsbruck, Austria
Actively Recruiting
2
Universidade de São Paulo
São Paulo, Brazil
Actively Recruiting
3
Universitätsklinikum Erlangen-Nürnberg, Abteilung für Nephrologie und Hypertensiologie
Erlangen, Germany, 91054
Actively Recruiting
4
Kliniken Maria Hilf, Klinik für Anästhesiologie und Operative Intensivmedizin
Mönchengladbach, Germany, 41063
Actively Recruiting
5
University Hospital Muenster
Münster, Germany, D-48149
Actively Recruiting
Research Team
A
Alexander Zarbock, MD
M
Melanie Meersch-Dini, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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