Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT ( KETZEREI )
NCT ID: NCT06021288
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
165 participants
INTERVENTIONAL
2023-10-02
2025-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Intervention Group
CRRT will be established with a draining dose (effluent dose) of 10-15ml/kg/h in pursuit of establishing a controlled azotaemia.
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.
Control Group
Standard of Care:
CRRT will be established with a draining dose (effluent dose) of 25-30ml/kg/h
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Critically ill patients with AKI + in need of CRRT
* Written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Universität Münster
OTHER
Responsible Party
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Principal Investigators
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Alexander Zarbock, MD
Role: STUDY_CHAIR
WWU Münster
Locations
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University Hospital Münster
Münster, , Germany
Universitätsklinikum Tübingen; Universitätsklinik für Anästhesiologie und Intensivmedizin
Tübingen, , Germany
Countries
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Central Contacts
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References
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Strauss C, Sadjadi M, von Groote T, Booke H, Schone LM, Hegner C, Wempe C, Meersch M, Gerss J, Bernard A, Haeberle HA, Rosenberger P, Rahmel T, Unterberg M, Adamzik M, Arndt C, Wulf H, Romagnoli S, Bonizzoli M, Mandarano R, Premuzic V, Andrade L, Smolentzov I, Bagshaw SM, Chawla L, Zarbock A. Randomised controlled study investigating standard dose continuous renal replacement therapy (CRRT) versus low-dose CRRT in critically ill patients with acute kidney injury (AKI): study protocol for a prospective, randomised, controlled, international, multicentre trial (the 'Ketzerei' trial). BMJ Open. 2025 Sep 22;15(9):e105459. doi: 10.1136/bmjopen-2025-105459.
Beaubien-Souligny W, Thompson Bastin M, Teixeira JP, Cerda J, Connor MJ Jr, Dijanic Zeidman A, Garimella PS, Juncos L, Lopez-Ruiz A, Mehta R, Reis T, Rizo-Topete L, Silver SA, Da Silva JR, Speer R, Vijayan A, Wells C, Wille K, Yessayan L, Tolwani A, Neyra JA. Proceedings of the University of Alabama at Birmingham Continuous Renal Replacement Therapy Academy (2023-2024): Managing De-Escalation of Acute Renal Replacement Therapy and Optimizing Drug Dosing during Renal Replacement Therapy Transitions. Kidney360. 2025 Oct 1;6(10):1798-1809. doi: 10.34067/KID.0000000951. Epub 2025 Aug 8.
Other Identifiers
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AnIt23-06
Identifier Type: -
Identifier Source: org_study_id