Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT ( KETZEREI )

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Study Investigating Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT - The Ketzerei Trial

Conditions
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Critical Illness, Acute Kidney Injury

Intervention / Treatment
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* Other: Effluent dose of CRRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (age ≥18 years) Critically ill patients with AKI + in need of CRRT Written informed consent Exclusion Criteria: Chronic dialysis dependency Chronic kidney disease with estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m² severe liver cirrhosis (Child-pugh C) severe acidosis (pH < 7,20 at study enrolment) severe hyperkalaemia (> 6mmol/l) Pregnancy or breastfeeding persons held in an institution by legal or official order Dependency on the investigator or center

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br>* 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.<br>|
| Active Comparator: Control Group<br>Standard of Care: CRRT will be established with a draining dose (effluent dose) of 25-30ml/kg/h | Other: Effluent dose of CRRT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days alive and free from CRRT |  | Between Randomization and day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Composite endpoint consisting of death, renal replacement therapy, and persistent severe AKI lasting for 72 hours or more | Day 30 after randomization | 
| Expense of treatment (including hospital stay/all measures taken) |  | From randomization until day 30 after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous renal replacement therapy