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

Universität Münster165 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

165

Conditions

Critical Illness Acute Kidney Injury

Interventions

Effluent dose of CRRTOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University Hospital Münster

Münster, Germany

RECRUITING

Universitätsklinikum Tübingen; Universitätsklinik für Anästhesiologie und Intensivmedizin

Tübingen, Germany

RECRUITING

Outcomes

Primary Outcomes

Number of days alive and free from CRRT

Time frame: Between Randomization and day 28

Secondary Outcomes

Number of Adverse Events (rooted in uraemia, i.e. throwing up, seizures, uremic coma etc.)

Time frame: Between randomization and day 28

Number of days with renal replacement therapy

Time frame: Between randomization and day 28

Length of Intensive Care Unit (ICU) stay

Time frame: Between randomization and day 28

Length of Hospital stay

Time frame: Between randomization and day 28

Mortality

Time frame: Day 30 after randomization

Number of new infections since randomization

Time frame: From randomization until day 30

Total amount of dialysis fluid utilized adjusted for weight

Time frame: From randomization until day 30

Number of patients alive and dialysis-free at day 30

Time frame: 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

Time frame: Day 30 after randomization

Expense of treatment (including hospital stay/all measures taken)

Central Contacts

Alexander Zarbock, MD

CONTACT

+492518347255 aki@anit.uni-muenster.de

Melanie Meersch-Dini, MD

CONTACT

+492518347255 aki@uni-muenster.de

Data from ClinicalTrials.gov

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