Critical IllnessKETZEREINCT06021288
Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT ( KETZEREI )
A study testing Effluent dose of CRRT in people with Critical Illness and Acute Kidney Injury, run by Universität Münster at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Acute Kidney Injury
- What is being tested?
- Effluent dose of CRRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 2 sitesGermany
- Study dates
- 2 Oct 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥18 years)
- Critically ill patients with AKI + in need of CRRT
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Münster
Münster, 48149
- Recruiting
Universitätsklinikum Tübingen; Universitätsklinik für Anästhesiologie und Intensivmedizin
Tübingen, 72076
About this study
Official title: A Randomized Controlled Study Investigating Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT - The "Ketzerei" Trial
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.
- Conditions
- Critical Illness, Acute Kidney Injury
- Being tested
- Effluent dose of CRRT
- Keywords
- Continuous renal replacement therapy
- Medical subject headings
- Critical Illness, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effluent dose of CRRTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Effluent dose of CRRT |
| Control Group | Active comparator | Standard of Care:
CRRT will be established with a draining dose (effluent dose) of 25-30ml/kg/h Receives: Other: Effluent dose of CRRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days alive and free from CRRT
Measured: Between Randomization and day 28
Secondary outcomes (10)
Number of Adverse Events (rooted in uraemia, i.e. throwing up, seizures, uremic coma etc.)
Measured: Between randomization and day 28
Number of days with renal replacement therapy
Measured: Between randomization and day 28
Length of Intensive Care Unit (ICU) stay
Measured: Between randomization and day 28
Length of Hospital stay
Measured: Between randomization and day 28
Mortality
Measured: Day 30 after randomization
Number of new infections since randomization
Measured: From randomization until day 30
Total amount of dialysis fluid utilized adjusted for weight
Measured: From randomization until day 30
Number of patients alive and dialysis-free at day 30
Measured: 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
Measured: Day 30 after randomization
Expense of treatment (including hospital stay/all measures taken)
Measured: From randomization until day 30 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start2 Oct 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Münster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Zarbock, MD, Study chair, WWU Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021288
- Sponsor's protocol ID
- AnIt23-06
- Acronym
- KETZEREI
- Status last verified
- Nov 2024
- First submitted
- 15 Aug 2023
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40983574Beaubien-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.
PubMed 40779331
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Investigating Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT - The "Ketzerei" Trial
- ClinicalTrials.gov ID
- NCT06021288
- Acronym / sponsor ID
- KETZEREI / AnIt23-06
- Conditions
- Critical Illness, Acute Kidney Injury
- Keywords
- Continuous renal replacement therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Universität MünsterUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Effluent dose of CRRTCRRT 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 | Other: Effluent dose of CRRTStandard of Care: CRRT will be established with a draining dose (effluent dose) of 25-30ml/kg/h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age ≥18 years)
- Critically ill patients with AKI + in need of CRRT
- Written informed consent
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effluent dose of CRRTThe 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. | Other | Control Group, Intervention Group |
Primary outcome
Number of days alive and free from CRRT
Time frame: Between Randomization and day 28
10 secondary outcomes
Number of Adverse Events (rooted in uraemia, i.e. throwing up, seizures, uremic coma etc.)
Time frame: Between randomization and day 28
Number of days with renal replacement therapy
Time frame: Between randomization and day 28
Length of Intensive Care Unit (ICU) stay
Time frame: Between randomization and day 28
Length of Hospital stay
Time frame: Between randomization and day 28
Mortality
Time frame: Day 30 after randomization
Number of new infections since randomization
Time frame: From randomization until day 30
Total amount of dialysis fluid utilized adjusted for weight
Time frame: From randomization until day 30
Number of patients alive and dialysis-free at day 30
Time frame: Day 30 after randomization
Presence of Major adverse kidney events (MAKE)
Time frame: Day 30 after randomization
Expense of treatment (including hospital stay/all measures taken)
Time frame: From randomization until day 30 after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Derived from this study: PubMed 40983574Strauss 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.
- Derived from this study: PubMed 40779331Beaubien-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Zarbock, MD study chair
WWU Münster
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effluent dose of CRRT in people with Critical Illness and Acute Kidney Injury, run by Universität Münster at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Zarbock, MD (+492518347255, aki@anit.uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days alive and free from CRRT (time frame: Between Randomization and day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06021288, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.