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NCT03635606 · ClinicalTrials.gov registry record

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

A clinical trial of Coronary Artery Disease, sponsored by Sapere Bio.

Completed
Registry status
370
Enrollment target
3
Study locations

NCT03635606: Completed study of Coronary Artery Disease, sponsored by Sapere Bio.

NCT03635606 is a study of Coronary Artery Disease that has completed, run by Sapere Bio. The registered enrollment target is 370 participants, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (71% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03635606, a study of Coronary Artery Disease, has completed, sponsored by Sapere Bio.

COMPLETED
Registry status
370 participants
Enrollment target
3
Study locations

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 Studied

Study Locations (3)

California

  • Hoag Memorial Hospital Presbyterian - Newport Beach

Maryland

  • Johns Hopkins University - Baltimore

North Carolina

  • WakeMed Health and Hospitals - Raleigh

Trial Details

FieldValue
Enrollment Target 370 participants
Start Date 2020-02-24
Est. Completion 2023-02-28
Sapere Bio

5 total trials

What the finished NCT03635606 record still lists

NCT03635606 is an observational study that tracks outcomes without assigning an intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (71% lower).

The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 0 interventions.

NCT03635606 reports a single indexed study location in California, Maryland, North Carolina.

Frequently Asked Questions

What is clinical trial NCT03635606 about?

NCT03635606 is a clinical study titled "GUARD-AKI: Validation of AKI-Sapere in Cardiac Surgery Patients". 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...

What is the current status of trial NCT03635606?

This trial is currently completed. The enrollment target is 370 participants. The study started on 2020-02-24. Estimated completion is 2023-02-28.

What conditions does trial NCT03635606 study?

This clinical trial studies the following conditions: Coronary Artery Disease.

Who is sponsoring clinical trial NCT03635606?

This trial is sponsored by Sapere Bio, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03635606 being conducted?

This trial has 3 study locations across California, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Coronary Artery Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03635606's enrollment target sits among peer trials

370 92nd of 219 higher than 128 of 219 other Coronary Artery Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03635606, the US trial registry maintained by the National Library of Medicine. NCT03635606 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.