Acute Kidney Injury (Nontraumatic)
Conditions
Keywords
cardiac surgery, KDIGO-Guideline
Brief summary
There is no specific therapy for acute kidney injury. It is presumed that supportive measures improve the care and outcome of patients with acute kidney injury. The investigators hypothesize that the implementation of a bundle of supportive measures adapted to patients undergoing cardiovascular surgery reduces the occurence of AKI. A Randomized prospective multicenter trial is needed to investigate whether the implementation of the bundle of measures is effective to prevent AKI in high risk patients undergoing cardiac surgery. In this feasibility trial the investigators will analyze the compliance rate to the trial protocol in a multicenter, multinational cohort in preparation for a large randomized controlled trial.
Interventions
OTHERIntervention
Implementation of the cardiovascular AKI bundle (see arm description)
Sponsors
European Society of Intensive Care Medicine
University Hospital Muenster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) * Urinary \[TIMP-2\] \* \[IGFBP7\] \>= 0.3 4h after CPB * Written informed consent
Exclusion criteria
* Preexisting AKI (stage 1 and higher) * Patients with cardiac assist devices (ECMO, LVAD, RVAD, IABP) * Pregnancy, breastfeeding * Known (Glomerulo-)-Nephritis, intersstitial nephritis or vasculitis * CKD with eGFR \< 20 mL/min * Dialyses dependent CKD * Prior kidney transplant within the last 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance rate | 48 hours after start of intervention | proportion of patients who are treated according to the trial protocol: CV surgery AKI bundle fulfilled at all time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Moderate and severe AKI | 72 hours after start of intervention | — |
| Free-days through of vasoactive medications and mechanical ventilation | 28 days after start of intervention | — |
| Renal recovery | 90 days after start of intervention | renal recovery is defined as serum creatinine levels \< 0.5 mg/dl higher than baseline serum creatinine (creatinine level before surgery) |
| Occurence of AKI | 72 hours after start of intervention | — |
| ICU and hospital stay | up to 1 year after start of intervention (until discharge) | — |
| Number of patients with renal replacement therapy | 90 days after start of intervention | — |
| Mortality | 90 days after start of intervention | — |
Countries
Belgium, Germany, Italy, Spain, United Kingdom
Outcome results
None listed