Biomarker Guided Intervention for Prevention of Acute Kidney Injury

NCT ID: NCT02500394

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-01-31

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).

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

standard care

Patients in the standard care population receive - if biomarkers are elevated -treatment of AKI in accordance with KDIGO 2012 guidelines

Group Type: PLACEBO_COMPARATOR

Ionosteril

Intervention Type: PROCEDURE

biomarker guided volume substitution with Ionosteril

interventional care

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

Group Type: ACTIVE_COMPARATOR

Ionosteril

Intervention Type: PROCEDURE

biomarker guided volume substitution with Ionosteril

Interventions

Ionosteril

biomarker guided volume substitution with Ionosteril

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Regensburg

OTHER

Sponsor Role: lead

Responsible Party

Tobias, Bergler, MD

PD Dr Tobias Bergler, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias Bergler, MD

Role: PRINCIPAL_INVESTIGATOR

UKR-Department of Nephrology

Ivan Göcze, MD

Role: PRINCIPAL_INVESTIGATOR

UKR-Department of Surgery

Locations

University Hospital Center Regensburg

Regensburg, , Germany

Countries

Germany

Other Identifiers

1476-Version 6

Identifier Type: -

Identifier Source: org_study_id