NCT05924269

Brief Summary

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.

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Typical duration for all trials

Status
not yet recruiting

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

June 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

2.9 years

First QC Date

June 20, 2023

Last Update Submit

July 3, 2023

Conditions

Keywords

Neuronal Guidance ProteinAcute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • AKI

    Development of AKI after cardiac surgery

    1-7 days

Secondary Outcomes (1)

  • NGP

    1-7 days

Study Arms (1)

Cardiac Surgery

Patients undergoing cardiac surgery

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients undergoing cardiac surgery
  • written consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

  • Andreas Körner, MD

    University Clinic of Tuebingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

June 29, 2023

Study Start

August 1, 2023

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

July 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share