Biomarker Guided Intervention for Prevention of Acute Kidney Injury

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Procedure: Ionosteril

• Registration Number: NCT02500394
• Lead Sponsor: University Hospital Regensburg

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).

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Not provided

Exclusion Criteria

• age < 18 years,
• end stage renal disease (ESRD),
• preexisting dialysis,
• withdrawal of consent,
• pregnancy,
• breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interventional care	Ionosteril	Patients in the interventional population receive - if biomarkers are elevated - individualized treatment/volume substitution (balanced electrolyte solution = Ionosteril; 1,25-5 ml/kg/bw/6 hours) ) on the basis of predefined criteria
standard care	Ionosteril	Patients in the standard care population receive - if biomarkers are elevated -treatment of AKI in accordance with KDIGO 2012 guidelines

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
length of ICU stay	90 days	overall length of ICU stay
length of hospital stay	90 days	overall length of ICU stay
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
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
need for renal replacement therapy,	90 days	Number of participants with a need for renal replacement therapy (defined as dialysis within 90 days)

Trial Locations

Locations (1)

University Hospital Center Regensburg; 🇩🇪 Regensburg, Germany