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NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

RECRUITINGPhase 2Sponsored by Kaiser Permanente
Actively Recruiting
PhasePhase 2
SponsorKaiser Permanente
Started2021-09-13
Est. completion2025-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

Summary

A Randomized, Double-blind, placebo-controlled Trial to Evaluate the Efficacy of Oral Nam for the Prevention of Acute Kidney Injury in Patients Undergoing On-Pump Cardiac Surgery

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria

* Informed consent before any study-related activities.
* Men or women \>18 years of age who are scheduled for non-emergent cardiac surgery procedures requiring CPB and are at increased risk for surgery-related adverse cardiovascular outcomes.

Procedures include:

* CABG
* Aortic, mitral, tricuspid, or pulmonic valve replacement or repair
* CABG with aortic, mitral, tricuspid, and/or pulmonic valve replacement

Risk factors for surgery related to adverse cardiovascular outcomes include one or more of the following:

* Valve surgery
* eGFR \< 45 ml/min/1.73m2
* Documented LVEF ≤ 35% within six months before surgery
* Documented history of heart failure
* Insulin-requiring diabetes
* Non-insulin-requiring diabetes and the presence of ≥+2 proteinuria on urinalysis (or equivalent on urine protein-to-creatinine ratio or urine albumin-to-creatinine ratio)
* Preoperative anemia (hemoglobin \<11g/dl for men and women)
* History of prior CABG
* Age ≥65

Exclusion Criteria

* Preexisting AKI within seven days before surgery as defined by KDIGO stage ≥1 (serum creatinine-based)
* Kidney transplant status
* Off-pump cardiac surgery
* ESRD
* Emergent cardiac surgery
* Pregnancy
* Patient enrolled in competing research studies that may affect outcomes
* Patients held in an institution by legal or official order

Conditions4

Acute Kidney InjuryHeart DiseaseIschemia-Reperfusion InjuryMyocardial Injury

Locations1 site

Kaiser Permanente San Francisco Medical Center
San Francisco, California, 94115
Ali Poyan Mehr, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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