Clinical Trials Directory

Trials / Completed

CompletedNCT03635606

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

Validation of AKI-Sapere Model to Predict Patients at Risk for AKI After Cardiac Surgery: GUARD-AKI (GUiding Against Reserve Decline)

Status
Completed
Phase
Study type
Observational
Enrollment
370 (actual)
Sponsor
Sapere Bio · Industry
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2020-02-24
Primary completion
2022-09-01
Completion
2023-02-28
First posted
2018-08-17
Last updated
2023-04-04

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03635606. Inclusion in this directory is not an endorsement.