An Evaluation of Patient Reported Outcomes and Clinical Outcomes

N/AActive Not RecruitingNCT06092970

Renibus Therapeutics, Inc.379 enrolled

Overview

This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery: * Patient reported outcomes (PRO), using the EQ-5D questionnaire * Clinical outcomes

Study Type

OBSERVATIONAL

Enrollment

379

Conditions

Post-Operative Complications in Cardiac Surgery

Interventions

RBT-1DRUG

Intravenous administration

PlaceboDRUG

Intravenous administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study. Exclusion Criteria: * Subjects who did not complete the REN-007 study are not eligible to participate in the Extension Study. * Female subjects who become pregnant during the REN-007 study are not eligible to participate in the Extension Study.

Locations (39)

Outcomes

Primary Outcomes

Evaluation

To evaluate patient reported outcomes (PRO) using the EQ-5D questionnaire

Time frame: 12 Months Post-Cardiac Surgery

Evaluation

The number of subjects with the following clinical outcomes will be reported Clinical Outcomes: * Chronic kidney disease (CKD) - new diagnosis * Acute kidney injury (AKI) or CKD requiring dialysis * Atrial fibrillation - new-onset * Death * Myocardial infarction (MI) * Non-fatal cardiac arrest * Readmission to hospital * Reoperation for coronary artery bypass graft (CABG) and/or valve dysfunction * Stroke

Time frame: 12 Months Post-Cardiac Surgery

Data from ClinicalTrials.gov

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Research Site

Huntsville, Alabama, United States

Research Site

San Francisco, California, United States

Research Site

Stanford, California, United States

Research Site

Washington D.C., District of Columbia, United States

Research Site

Atlantis, Florida, United States

Research Site

Gainesville, Florida, United States

Research Site

Athens, Georgia, United States

Research Site

Atlanta, Georgia, United States

Research Site

Fort Wayne, Indiana, United States

Research Site

Indianapolis, Indiana, United States

...and 29 more locations