N17.8
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Major surgery (cardiac surgery, abdominal surgery, and vascular surgery) with a duration of > 2h - Planned admission to the Intensive Care Unit, Intermediate Care or PACU after surgery - One of the following Risk factors: a. Age >70 years b. Use of catecholamines c. CKD d. Mechanical ventilated - Written informed consent
Exclusion criteria
Exclusion criteria: - Pre-existing AKI - Kidney transplantation within the last 12 Months - End stage renal disease with dialysis dependency - COPD requiring permanent oxygen therapy - Alzheimer disease or dementia of any kind - High doses of corticosteroids (cutoff: Prednisolone (7,5 mg) or hydrocortisone (>3 mg form men, > 20 mg for women) ) - Any form of dependency to the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this trial is to determine whether patients with higher grade (grade 2-3) AKI have more AKI-associated complications than patients with lower grade (grade 1) or no AKI. •AKI-related complications during AKI stay; composite endpoint consisting of a.Cardiac arrhythmias – new onset of atrial fibrillation b.Delirium c.new onset of infection (infection with proved pathogen and increase of clinical infection marker (e.g. leukocytes, CRP, PCT) and the prescription of antibiotics) d.prolonged mechanical ventilation (longer than 12 hours) e.post-operative bleeding, defined as a blood loss that requires blood transfusion | — |
Secondary
| Measure | Time frame |
|---|---|
| • Use of renal replacement therapy • Length of ICU stay • Length of hospital stay • Survival • ICU mortality • Hospital mortality • MAKE90 (major adverse kidney events at day 90): combined endpoint consisting of: mortality, renal replacement therapy, and persistent renal dysfunction defined as serum-creatinine = 1.5 times as compared to baseline serum-creatinine | — |
Countries
Germany
Contacts
Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie; Universitätsklinikum Münster