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

Critical Illness Clinical Trial

— KETZEREI  

Official title:

A Randomized Controlled Study Investigating Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT - The "Ketzerei" Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021288
• Other study ID #: AnIt23-06
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Universität Münster
• Contact: Alexander Zarbock, MD
• Phone: +492518347255
• Email: aki[@]anit.uni-muenster.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: June 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Münster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
Universität Münster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days alive and free from CRRT		Between Randomization and day 28
Secondary	Number of Adverse Events (rooted in uraemia, i.e. throwing up, seizures, uremic coma etc.)		Between randomization and day 28
Secondary	Number of days with renal replacement therapy		Between randomization and day 28
Secondary	Length of Intensive Care Unit (ICU) stay		Between randomization and day 28
Secondary	Length of Hospital stay		Between randomization and day 28
Secondary	Mortality		Day 30 after randomization
Secondary	Number of new infections since randomization		From randomization until day 30
Secondary	Total amount of dialysis fluid utilized adjusted for weight		From randomization until day 30
Secondary	Number of patients alive and dialysis-free at day 30		Day 30 after randomization
Secondary	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
Secondary	Expense of treatment (including hospital stay/all measures taken)		From randomization until day 30 after randomization