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Status unknownNCT03830450AKIriskUpdated Nov 13, 2020

Biomarkers of Acute Kidney Injury in Cardiac Surgery

An observational study in Acute Kidney Injury (Nontraumatic), sponsored by Nikola Bradic, MD. Status unknown. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by Nikola Bradic, MD · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 80 Years
Sex
All
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Study 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.

02

Conditions studied

  • Acute Kidney Injury (Nontraumatic)

Keywords

  • Acute kidney injury
  • Cardiac surgery
  • NGAL
  • GDF-15
03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's planned enrollment of 50 is below the median of 150 across 773 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

This is the only study on the registry with Nikola Bradic, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients scheduled for cardiac surgery with usage of cardiopulmonary bypass

Inclusion criteria

  • patients scheduled for cardiac surgery (CABG, valve replacement/repair, combined)
  • older than 18 years

Exclusion criteria

Exclusion Criteria:

  • previous known renal disease
  • patients on chronic dialysis
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: One year

  2. 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

    Time frame: One year

  3. 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

    Time frame: One Year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03830450
Lead sponsor
Nikola Bradic, MD
Responsible party
Nikola Bradic, MD (MD, Senior Lecturer, University Hospital Dubrava) — Sponsor-investigator
First posted
Feb 5, 2019
Start date
Dec 1, 2020 (estimated)
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Nov 13, 2020

Study contacts

Nikola Bradic, MD
Contact
nbradic@kbd.hr
+385 91 589 3480

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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