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

Universität Münster2 sites in 1 country165 target enrollmentOctober 2, 2023

ConditionsCritical Illness Acute Kidney Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Critical Illness
Sponsor: Universität Münster
Enrollment: 165
Locations: 2
Primary Endpoint: Number of days alive and free from CRRT
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2, 2023

End Date

June 30, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universität Münster

Responsible Party

Sponsor

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

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.)(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)
Number of new infections since randomization(From randomization until day 30)