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

Not Applicable

Recruiting

• Conditions: Acute Kidney Injury; Critical Illness
• Interventions: Other: Effluent dose of CRRT

• Registration Number: NCT06021288
• Lead Sponsor: Universität Münster

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-31
• Study First Posted: 2023-09-01
• Study Start: 2023-10-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Effluent dose of CRRT	Standard of Care: CRRT will be established with a draining dose (effluent dose) of 25-30ml/kg/h
Intervention Group	Effluent dose of CRRT	CRRT will be established with a draining dose (effluent dose) of 10-15ml/kg/h in pursuit of establishing a controlled azotaemia.

Primary Outcome Measures

Name	Time	Method
Number of days alive and free from CRRT	Between Randomization and day 28

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events (rooted in uraemia, i.e. throwing up, seizures, uremic coma etc.)	Between randomization and day 28
Mortality	Day 30 after randomization
Number of patients alive and dialysis-free at day 30	Day 30 after randomization
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
Expense of treatment (including hospital stay/all measures taken)	From randomization until day 30 after randomization
Total amount of dialysis fluid utilized adjusted for weight	From randomization until day 30
Presence of Major adverse kidney events (MAKE)	Day 30 after randomization	Composite endpoint consisting of death, renal replacement therapy, and persistent severe AKI lasting for 72 hours or more
Number of new infections since randomization	From randomization until day 30

Trial Locations

Locations (2)

Universitätsklinikum Tübingen; Universitätsklinik für Anästhesiologie und Intensivmedizin; 🇩🇪 Tübingen, Germany

University Hospital Münster; 🇩🇪 Münster, Germany