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

NCT06021288 | Recruiting DMC

• 1 other identifier: AnIt23-06
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 2

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.

Conditions

Critical Illness; Acute Kidney Injury

Keywords

Continuous renal replacement therapy

Outcome Measures

Primary Outcomes (1)

• Number of days alive and free from CRRT

  Between Randomization and day 28

Secondary Outcomes (10)

• 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

Study Arms (2)

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.

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

Other: Effluent dose of CRRT

Interventions

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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (age ≥18 years)
• Critically ill patients with AKI + in need of CRRT
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Münster: lead

Study Sites (2)

University Hospital Münster

Münster, 48149, Germany

RECRUITING

Universitätsklinikum Tübingen; Universitätsklinik für Anästhesiologie und Intensivmedizin

Tübingen, 72076, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 40983574 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.

  PMID: 40779331 DERIVED

MeSH Terms

Conditions

Critical Illness; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Alexander Zarbock, MD

  WWU Münster

  STUDY CHAIR

Central Study Contacts

Alexander Zarbock, MD

CONTACT

+492518347255; aki@anit.uni-muenster.de

Melanie Meersch-Dini, MD

CONTACT

+492518347255; aki@uni-muenster.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 1, 2023
• Study Start: October 2, 2023
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

DE (2)