NCT03830450

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

February 2, 2019

Last Update Submit

November 10, 2020

Conditions

Keywords

Acute kidney injuryCardiac surgeryNGALGDF-15

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for cardiac surgery with usage of cardiopulmonary bypass

You may qualify if:

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

You may not qualify if:

  • previous known renal disease
  • patients on chronic dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Nikola Bradic, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, Senior Lecturer

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 5, 2019

Study Start

December 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

November 13, 2020

Record last verified: 2020-11