Role of Neuronal Guidance Proteins as Diagnostic Markers for Acute Kidney Injury (AKI) (NEUKID)

Acute kidney failure remains one of the most challenging entities to diagnose in clinical medicine, especially in the field of intensive care. The diagnosis of acute kidney injury is based solely on urine output and serum creatinine, both of which could also be influenced by other factors. A more sensitive and faster diagnostic option would not only be desirable but of utmost clinical importance. Therefore, the investigators aim to identify Neuronal Guidance Proteins (NGPs) as potential biomarkers for the identification and early detection of AKI with this investigation. This investigation aims to identify the possibility of diagnosing acute kidney injury, the subsequent validation of a potential biomarker will then have to take place in a multicenter study approach: Data in preclinical mouse models suggest that SEMA7A as one of the NGPs could be valuable as a biomarker, the study now aims to attempt a preliminary survey in humans and measure various NGPs.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Kidney Injury

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Andreas Körner, MD; Phone Number: +497071-29 61783; Email: andreas.koerner@med.uni-tuebingen.de
• Study Contact Backup: Name: Michael Koeppen, MD; Phone Number: +497071-29 86935; Email: michael.koeppen@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing elective cardiac surgery followed by postoperative surveillance in the intensive care unit

Description

Inclusion Criteria:

• Patients undergoing cardiac surgery
• written consent

Exclusion Criteria:

• no written consent possible
• Polytrauma, severe burns
• Immunosuppression
• Pregnancy
• Diagnosis of Hepatitis B, Hepatitis C, and/or HIV
• Sepsis
• Pre-existing kidney damage

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cardiac Surgery; Patients undergoing cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AKI	Development of AKI after cardiac surgery	1-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NGP	Concentration of NGPs in Blood and Urine	1-7 days

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Andreas Körner, MD, University Clinic of Tuebingen

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Acute Kidney Injury; Neuronal Guidance Protein
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: NEUKID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No