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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Acute Kidney Injury
• Intervention / Treatment: Other: Effluent dose of CRRT

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Zarbock, MD; Phone Number: +492518347255; Email: aki@anit.uni-muenster.de
• Study Contact Backup: Name: Melanie Meersch-Dini, MD; Phone Number: +492518347255; Email: aki@uni-muenster.de

Study Locations

• Germany
  • Münster, Germany, 48149
    • Recruiting
    • University Hospital Munster
  • Tübingen, Germany, 72076
    • Recruiting
    • Universitätsklinikum Tübingen; Universitätsklinik für Anästhesiologie und Intensivmedizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universität Münster
• Investigators: Study Chair: Alexander Zarbock, MD, WWU Münster

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Continuous renal replacement therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Renal Insufficiency; Critical Illness; Acute Kidney Injury
• Other Study ID Numbers: AnIt23-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No