Biomarker Guided Intervention for Prevention of Acute Kidney Injury

Acute Kidney Injury Clinical Trial

— BigpAK  

Official title:

Biomarker Guided Intervention to Prevent Development of Acute Kidney Injury in High-risk Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02500394
• Other study ID #: 1476-Version 6
• Status: Completed
• Phase: N/A
• First received: July 7, 2015
• Last updated: May 4, 2017
• Start date: June 2015
• Est. completion date: January 2017

Study information

• Verified date: May 2017
• Source: University Hospital Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

"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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Procedure:
• Ionosteril
biomarker guided volume substitution with Ionosteril

Locations

Country	Name	City	State
Germany	University Hospital Center Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of AKI in both group	incidence and severity of AKI according to AKI network definition within 90 days will be monitored	90 days
Secondary	need for renal replacement therapy,	Number of participants with a need for renal replacement therapy (defined as dialysis within 90 days)	90 days
Secondary	length of ICU stay	overall length of ICU stay	90 days
Secondary	length of hospital stay	overall length of ICU stay	90 days
Secondary	ICU and hospital costs	to account for resulting costs, ICU and hospital cost of the standard care and the interventional patient population are monitored	90 days
Secondary	incidence of chronic kidney disease (CKD)	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	90 days
Secondary	death	overall mortality	90 days