Acute Kidney Injury, Critical Illness
Conditions
Keywords
Continuous renal replacement therapy
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.
Interventions
OTHEREffluent 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.
Sponsors
Universität Münster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days alive and free from CRRT | Between Randomization and day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Mortality | Day 30 after randomization | — |
| Number of Adverse Events (rooted in uraemia, i.e. throwing up, seizures, uremic coma etc.) | Between randomization and day 28 | — |
| Total amount of dialysis fluid utilized adjusted for weight | From randomization until day 30 | — |
| Number of patients alive and dialysis-free at day 30 | Day 30 after randomization | — |
| 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 |
| Expense of treatment (including hospital stay/all measures taken) | From randomization until day 30 after randomization | — |
| Number of new infections since randomization | From randomization until day 30 | — |
Countries
Germany
Contacts
Primary ContactAlexander Zarbock, MD
Backup ContactMelanie Meersch-Dini, MD
Outcome results
None listed