Acute Kidney Injury
Conditions
Keywords
Continuous Renal Replacement Therapy (CRRT), Infection, filter change, critical illness
Brief summary
This study aims to investigate shorter vs. standard filter lifespans in critically ill patients receiving continuous renal replacement therapy (CRRT) for acute kidney injury (AKI). The aim of this trial is to reliably implement,scheduled filter changes and to investigate whether shorter filter lifetime is associated with a lower incidence in rate of new infections.
Detailed description
Own data of patients under standard care indicated that a longer filter lifetime in CRRT is associated with an increased rate of new infections. The aim of this study is to demonstrate that a protocolized filter-change strategy can be reliably implemented in critically ill patients and a high protocol adherence can be achieved. The secondary aim is to investigate whether a shorter filter-change strategy is be associated with a lower incidence of newly acquired infections.
Interventions
OTHERtime span of filter change
The time span of the filter change during continuous renal replacement therapy will be specified
Sponsors
Universität Münster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult ≥ 18 years 2. Critically ill patients with severe AKI consistent with KDIGO stage 3 and an absolute indication for CRRT 3. Written consent form from the patient or legal representative or authorized representative or emergency inclusion
Exclusion criteria
1. End-stage kidney disease or chronic dialysis dependence 2. Chronic kidney disease with eGFR\<20ml/min/1.73 m² 3. Prior kidney transplant 4. Prior renal replacement therapy during the index admission before randomization 5. Glomerulonephritis, interstitial nephritis, vasculitis 6. Patients on immunosuppression (above the cushing threshold) 7. Patients with chronic inflammatory diseases (e.g. arthritis, HIV with a CD4 count of \< 0.05 x 10E/l) 8. Do-not resuscitate order 9. Persons with any kind of dependency on the investigator or employed by the sponsor 10. Patients participating in an interventional study involving measures to influence the immune system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean filter lifespan per patient | From start of CRRT to end of CRRT or at day 30 after randomization, whatever occurs first | Comparison of mean filter lifespans between study groups |
| Protocol adherence as documented filter change within the specified period | From start of CRRT to end of CRRT or at day 30 after randomization, whatever occurs first | Proportion of protocol adherent patients, defined as patients with mean filter lifespan within the pre-specified time window in each arm (intervention group: 36±3hours; control group: 48-72hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New intensive care unit (ICU)-associated acquired infection up to day 30 | From start of CRRT to end of CRRT or at day 30 after randomization, whatever occurs first | Rate of new ICU-acquired infections, defined as new infection in patients with pre-existing infection but with another pathogen than baseline or without baseline infection. All infections need to be culture proven. Only the first infection per patient will be considered |
Countries
Germany
Contacts
CONTACTAlexander Zarbock, MD
CONTACTNadja Schöne, MD
STUDY_CHAIRAlexander Zarbock, MD
University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy
Outcome results
None listed