Clinical trial NCT02500394: Biomarker Guided Intervention for Prevention of Acute Kidney Injury
Official title: Biomarker Guided Intervention to Prevent Development of Acute Kidney Injury in High-risk Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: renal replacement therapy
Lead sponsor: University Hospital Regensburg
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: "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

Primary outcomes:
measure: Incidence and severity of AKI in both group
timeFrame: 90 days
Secondary outcomes:
measure: need for renal replacement therapy,
timeFrame: 90 days
measure: length of ICU stay
timeFrame: 90 days
measure: length of hospital stay
timeFrame: 90 days
measure: ICU and hospital costs
timeFrame: 90 days
measure: incidence of chronic kidney disease (CKD)
timeFrame: 90 days
measure: death
timeFrame: 90 days
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University Hospital Center Regensburg
Study officials:
affiliation: UKR-Department of Nephrology
name: Tobias Bergler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UKR-Department of Surgery
name: Ivan Göcze, MD
role: PRINCIPAL_INVESTIGATOR
References: