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GUARD-AKI: Validation of AKI-Sapere in Cardiac Surgery Patients

NCT03635606 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 370

Last updated 2023-04-04

No results posted yet for this study

Summary

Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI. The development of CSA-AKI is independently associated with an increased risk of in-hospital death. There are currently no biomarkers that could identify patients at higher risk for AKI and current risk predictor scores that are based on clinical and demographic information are inadequate. Therefore, a diagnostic test for predicting AKI risk in this clinical context would assist clinicians to optimize surgical strategy and postoperative care to prevent CSA-AKI occurrence and improve patient outcomes.

The primary purpose of this study is to validate a panel of biomarkers identified in the discovery study (referred to as AKI-Sapere prognostic) to identify patients at risk for all stages of CSA-AKI.

Conditions

Sponsors & Collaborators

  • WakeMed Health and Hospitals

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Hoag Memorial Hospital Presbyterian

    collaborator OTHER

  • Sapere Bio

    lead INDUSTRY

Principal Investigators

  • Natalia Mitin, PhD · Sapere Bio

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2022-09-01
Completion
2023-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03635606 on ClinicalTrials.gov