Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed No phase listed Observational

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

ClinicalTrials.gov ID: NCT03635606

Public ClinicalTrials.gov record NCT03635606. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 9:13 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03635606
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Sapere Bio
Industry
Enrollment
370 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
40 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 23, 2020
Primary completion
Aug 31, 2022
Completion
Feb 27, 2023
Last update posted
Apr 3, 2023

2020 – 2023

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
Hoag Memorial Hospital Presbyterian Newport Beach California 92663
Johns Hopkins University Baltimore Maryland 21287
WakeMed Health and Hospitals Raleigh North Carolina 27610

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03635606, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 3, 2023 · Synced Sep 6, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03635606 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →