Clinical trial NCT06021288: Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT ( KETZEREI )
Official title: A Randomized Controlled Study Investigating Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT - The "Ketzerei" Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Acute Kidney Injury
Keywords: Continuous renal replacement therapy
Lead sponsor: Universität Münster
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of days alive and free from CRRT
timeFrame: Between Randomization and day 28
Secondary outcomes:
measure: Number of Adverse Events (rooted in uraemia, i.e. throwing up, seizures, uremic coma etc.)
timeFrame: Between randomization and day 28
measure: Number of days with renal replacement therapy
timeFrame: Between randomization and day 28
measure: Length of Intensive Care Unit (ICU) stay
timeFrame: Between randomization and day 28
measure: Length of Hospital stay
timeFrame: Between randomization and day 28
measure: Mortality
timeFrame: Day 30 after randomization
measure: Number of new infections since randomization
timeFrame: From randomization until day 30
measure: Total amount of dialysis fluid utilized adjusted for weight
timeFrame: From randomization until day 30
measure: Number of patients alive and dialysis-free at day 30
timeFrame: Day 30 after randomization
measure: Presence of Major adverse kidney events (MAKE)
timeFrame: Day 30 after randomization
measure: Expense of treatment (including hospital stay/all measures taken)
timeFrame: From randomization until day 30 after randomization
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University Hospital Münster
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen; Universitätsklinik für Anästhesiologie und Intensivmedizin
Study officials:
affiliation: WWU Münster
name: Alexander Zarbock, MD
role: STUDY_CHAIR
References: