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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | CRRT will be established with a draining dose (effluent dose) of 10-15ml/kg/h in pursuit of establishing a controlled azotaemia. |
|
| Control Group | Active Comparator | Standard of Care: CRRT will be established with a draining dose (effluent dose) of 25-30ml/kg/h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Effluent dose of CRRT | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of days alive and free from CRRT | Between Randomization and day 28 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Zarbock, MD | Contact | +492518347255 | aki@anit.uni-muenster.de | |
| Melanie Meersch-Dini, MD | Contact | +492518347255 | aki@uni-muenster.de |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Zarbock, MD | WWU Münster | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Münster | Recruiting | Münster | 48149 | Germany | ||
| Universitätsklinikum Tübingen; Universitätsklinik für Anästhesiologie und Intensivmedizin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40983574 | Derived | 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. | |
| 40779331 |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
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| 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 |
| Recruiting |
| Tübingen |
| 72076 |
| Germany |
| Derived |
| 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. |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |