Filter Lifespan in Continuous Renal Replacement Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Critically ill patients with continuous renal replacement therapy.
- Who it may be relevant to
- Registry conditions: Critically Ill, Continuous Renal Replacement Therapy, Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Brazil, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
The only supportive therapy for patients with AKI is renal replacement therapy (RRT). In the ICU setting, continuous RRT (CRRT) is mostly favored. In a post-hoc analysis of the RICH trial (regional citrate versus systemic heparin anticoagulation for CRRT in critically ill patient with AKI), it was shown that the filter life span is associated with an increased rate of new infection and that the type of anticoagulants did not directly affect infection rate. The mechanisms of this infection rate is unknown.
Detailed description
Approximately every second patient in the ICU suffers from acute kidney injury (AKI) which complicates the clinical course of these patients. Continuous renal replacement therapy (CRRT) has become the most widely used form of renal support in critically ill patients as it allows continuous, controlled removal of fluids and is hemodynamically better tolerated compared to intermittent dialysis. The requirement for intravascular access and artificial circuits may increase the risk of infection. However, there are no studies analyzing the incidence and characteristics of infections in critically ill patients with CRRT or the implications for outcome. Therefore, this observational trial investigates the factors that influences new onset infection in critically ill patients with CRRT.
Interventions
- Procedure Critically ill patients with continuous renal replacement therapy
Due to the observational design of the study, no study-specific interventions are performed. The treatment of the patients is completely guided by the responsible ICU physicians.
Primary outcome measures
- Number of new infections since start of dialysis [Time frame: From start of dialysis until day 28]
Secondary outcome measures (12)
- Number of new blood stream infections [Time frame: From start of dialysis until day 28]
- Number of new pneumonia [Time frame: From start of dialysis until day 28]
- Number of new urinary tract infection [Time frame: From start of dialysis until day 28]
- Number of new catheter blood stream infection [Time frame: From start of dialysis until day 28]
- Number of new other infections [Time frame: From start of dialysis until day 28]
- Filter live span [Time frame: From start of dialysis until day 28 or end of CRRT, whatever occurs first]
- Number of bacterial contamination of t he CRRT circuit proven by culture [Time frame: From start of dialysis until day 28 or end of CRRT, whatever occurs first]
- Down-time of CRRT in hours [Time frame: From start of dialysis until day 28 or end of CRRT, whatever occurs first]
- Days on renal replacement therapy [Time frame: From start of dialysis until day 28]
- Duration of mechanical ventilation in hours [Time frame: From start of dialysis until day 28]
- Number of bleeding complications [Time frame: From start of dialysis until day 28]
- Recovery of kidney function [Time frame: At day 28 after start of dialysis]
Eligibility criteria
Inclusion criteria
- Adult patients (age ≥18 years)
- Critically ill patients with dialysis-dependent AKI
- Continuous renal replacement therapy (CRRT)
- Written informed consent
Exclusion criteria
- Chronic kidney disease with estimated glomerular filtration rate (eGFR)<30ml/min/1.73m2
- Chronic dialysis dependency
- Kidney transplant
- (Glomerulo-)nephritis, interstitial nephritis, vasculitis
- Patients on immunosuppression
- Patients with chronic inflammatory diseases (e.g. arthritis, HIV, chronic hepatitis)
- Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 3 centers
- Universitätsklinikum Erlangen-Nürnberg, Abteilung für Nephrologie und Hypertensiologie — Erlangen
- Kliniken Maria Hilf, Klinik für Anästhesiologie und Operative Intensivmedizin — Mönchengladbach
- University Hospital Muenster — Münster
Austria · 1 center
- Univ.-Klinik Innsbruck — Innsbruck
Brazil · 1 center
- Universidade de São Paulo — São Paulo
Identifiers
NCT: NCT05450185 · 10-AnIt-21