Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT ( KETZEREI )
Study Details
Study Description
Brief Summary
Acute kidney injury (AKI) is a well-recognized complication in critically ill patients, which often leads to the necessity of mechanical kidney support (CRRT).
In current therapeutic regimes, CRRT is used to strictly prevent azotaemia. Thus recent clinical observations, as well as data from animal testing suggest a link between controlled azotaemia and faster renal recovery in AKI patients.
The aim of the study is to improve renal recovery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Group CRRT will be established with a draining dose (effluent dose) of 10-15ml/kg/h in pursuit of establishing a controlled azotaemia. |
Other: Effluent dose of CRRT
The effluent dose of the CRRT will be performed according to study group for 7 days or up to the end of CRRT, whatever occurs first.
|
| Active Comparator: Control Group Standard of Care: CRRT will be established with a draining dose (effluent dose) of 25-30ml/kg/h |
Other: Effluent dose of CRRT
The effluent dose of the CRRT will be performed according to study group for 7 days or up to the end of CRRT, whatever occurs first.
|
Outcome Measures
Primary Outcome Measures
- Number of days alive and free from CRRT [Between Randomization and day 28]
Secondary Outcome Measures
- Number of Adverse Events (rooted in uraemia, i.e. throwing up, seizures, uremic coma etc.) [Between randomization and day 28]
- Number of days with renal replacement therapy [Between randomization and day 28]
- Length of Intensive Care Unit (ICU) stay [Between randomization and day 28]
- Length of Hospital stay [Between randomization and day 28]
- Mortality [Day 30 after randomization]
- Number of new infections since randomization [From randomization until day 30]
- Total amount of dialysis fluid utilized adjusted for weight [From randomization until day 30]
- Number of patients alive and dialysis-free at day 30 [Day 30 after randomization]
- Presence of Major adverse kidney events (MAKE) [Day 30 after randomization]
Composite endpoint consisting of death, renal replacement therapy, and persistent severe AKI lasting for 72 hours or more
- Expense of treatment (including hospital stay/all measures taken) [From randomization until day 30 after randomization]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult patients (age ≥18 years)
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Critically ill patients with AKI + in need of CRRT
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Written informed consent
Exclusion Criteria:
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Chronic dialysis dependency
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Chronic kidney disease with estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m²
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severe liver cirrhosis (Child-pugh C)
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severe acidosis (pH < 7,20 at study enrolment)
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severe hyperkalaemia (> 6mmol/l)
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Pregnancy or breastfeeding
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persons held in an institution by legal or official order
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Dependency on the investigator or center
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Münster | Münster | Germany | 48149 |
Sponsors and Collaborators
- Westfälische Wilhelms-Universität Münster
Investigators
- Study Chair: Alexander Zarbock, MD, WWU Münster
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AnIt23-06