Acute Kidney Injury
Conditions
Keywords
renal replacement therapy
Brief summary
This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients. Eligible patients are screened for marker of tubular stress in the urine; if patient specific results are above a pre-defined cutoff they are randomized into a standard care group or an interventional group in which patients receive intensified volume therapy.
Detailed description
This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients.Used markers have been identified as markers of tubular stress and have been validated in previous studies with more than 1500 patients. The advantage of a biomarker guided approach is the saving of time for the diagnosis a developing acute kidney injury (AKI) in high risk surgical patients, since clinical signs of AKI (rise in creatinine/decline of estimated Glomerular Filtration Rate (eGFR), decline of diuresis). If used biomarkers are above a predefined cutoff within \< 4 hours after surgery, patients are randomized in to a standard care population receiving treatment in accordance with Kidney Disease Improving Global Outcomes (KDIGO) guidelines. In the intervention population patients receive individual volume therapy (= balanced electrolyte solution (Ionosteril)) (1,25 ml/kg bw up to 5 ml/kg bw for 6 hours). Degree of volume therapy is estimated by several predifined parameters, e.g. central venous pressure (CVP).
Interventions
PROCEDUREIonosteril
biomarker guided volume substitution with Ionosteril
Sponsors
University Hospital Regensburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* major surgery with a duration \> 4 hours plus one of the following criteria: * age \> 75 years, or * sepsis, or * shock, or * polytrauma, or * need for invasive ventilation or catecholamines, or * intra-operative application of contrast-medium, or * preexisting chronic kidney disease (CKD1-4), * informed consent
Exclusion criteria
* age \< 18 years, * end stage renal disease (ESRD), * preexisting dialysis, * withdrawal of consent, * pregnancy, * breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of AKI in both group | 90 days | incidence and severity of AKI according to AKI network definition within 90 days will be monitored |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| length of ICU stay | 90 days | overall length of ICU stay |
| length of hospital stay | 90 days | overall length of ICU stay |
| need for renal replacement therapy, | 90 days | Number of participants with a need for renal replacement therapy (defined as dialysis within 90 days) |
| incidence of chronic kidney disease (CKD) | 90 days | Investigators want to see if there are any differences on resulting renal function - different stages of chronic kidney disease (CKD I-V) as a consequence of the performed therapy: standard care accoring to KDIGO guidelines versus interventional care |
| death | 90 days | overall mortality |
| ICU and hospital costs | 90 days | to account for resulting costs, ICU and hospital cost of the standard care and the interventional patient population are monitored |
Countries
Germany
Outcome results
None listed