Biomarkers of Acute Kidney Injury in Cardiac Surgery

Acute Kidney Injury (Nontraumatic) Clinical Trial

— AKIrisk  

Official title:

Biomarkers in Estimation for Risk of Acute Kidney Injury in Cardiac Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03830450
• Other study ID #: University North
• Status: Not yet recruiting
• Start date: December 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2020
• Source: University Hospital Dubrava
• Contact: Nikola Bradic, MD
• Phone: +385 91 589 3480
• Email: nbradic[@]kbd.hr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Acute kidney injury (AKI) is the most common complication in patients after cardiac surgery. An usual estimation of risk for AKI is estimation of serum creatinine, which is unreliable indicator of AKI risk. Because of that, today different biomarkers are investigated to predict incidence for development AKI after cardiac surgery. This investigation will try to find potentially risk patients for developing AKI after cardiac surgery by using conventional markers (creatinine, glomerular filtration rate) in perioperative period comparing with two different biomarkers neutrophil gelatinase-associated lipocalin (NGAL) and growth differentiation factor 15 (GDF-15) which are proven markers in patients with increased risk for AKI development.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients scheduled for cardiac surgery (CABG, valve replacement/repair, combined)

• older than 18 years

Exclusion Criteria:

• previous known renal disease

• patients on chronic dialysis

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury (Nontraumatic)
• Wounds and Injuries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nikola Bradic, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consecutive values of neutrophil gelatinase-associated lipocalin (NGAL)	By the changing of NGAL values in consecutive measuring, predict which patients are in increased risk for development of AKI	One year
Primary	Consecutive values of growth differentiation factor 15 (GDF-15)	By the changing of GDF-15 values in consecutive measuring, predict which patients are in increased risk for development of AKI	One year
Primary	Consecutive values of glomerular filtration rate (GFR)	By the changing of GFR values in consecutive measuring, predict which patients are in increased risk for development of AKI	One Year