NACAM: NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
Study Details
Study Description
Brief 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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
This trial is a single-center, randomized, double-blind placebo-controlled Trial of Nam versus placebo in patients undergoing on-pump cardiac surgery. After screening and enrollment, patients will be stratified according to CKD status (eGFR<45 ml/min/m2) and surgical site and randomized in a 1:1 manner to receive either Nam 3 grams or placebo on the day of surgery and post-surgical days one and two.
The overall trial duration is planned for 42 months, consisting of 39 months of active recruitment and treatment period and three months of follow-up from the last patient enrolled.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Oral niacinamide
|
Drug: Niacinamide
Niacinamide 3 grams on the day of surgery and post-surgical days one and two
|
Placebo Comparator: Matched placebo
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Drug: Placebo
Matched placebo on the day of surgery and post-surgical days one and two
|
Outcome Measures
Primary Outcome Measures
- Troponin T AUC [From baseline to three days after surgery]
Troponin T AUC, composed of single daily serum measurements
Secondary Outcome Measures
- Mean difference in uQuin/Tryp ratio AUC [From baseline to three days after surgery]
Mean difference in uQuin/Tryp ratio AUC composed of single daily serum measurements
- Mean difference in eGFR [From baseline through day 5.]
Mean difference in eGFR (CKD-EPI formula)
Other Outcome Measures
- Number of Participants with the following Adverse Events and Serious Adverse Events [From baseline through day 90]
Postoperative dysrhythmias Postoperative re-hospitalization. Heart failure Surgical wound infection Transfusion requiring perioperative bleed Post-surgical deep vein thrombosis and pulmonary emboli Nosocomial infection Nausea and vomiting Adverse events leading to treatment discontinuation Perioperative liver injury (x2 upper normal-limit) Post-operative thrombosis and pulmonary emboli Impairment of renal function (KDIGO AKI)
- Length of index hospital stay. [From baseline through day 90]
• Mean length of index hospital stay (days)
- Length of intensive care unit stay. [From baseline through day 90]
• Mean length of intensive care unit stay (days)
- Perioperative inotropic-score and vasoactive-inotropic score. [At 6, 12, 24, and 48 hours post operatively]
• Mean inotropic-score and vasoactive-inotropic score
- Perioperative fluid volume administration. [From baseline through day 2]
• Mean daily perioperative fluid volume administration
- Perioperative brain-natriuretic peptide AUC [From baseline to three days after surgery]
BNP AUC, composed of single daily serum measurements
Eligibility Criteria
Criteria
Inclusion Criteria
-
Informed consent before any study-related activities.
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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:
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CABG
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Aortic, mitral, tricuspid, or pulmonic valve replacement or repair
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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:
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Valve surgery
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eGFR < 45 ml/min/1.73m2
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Documented LVEF ≤ 35% within six months before surgery
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Documented history of heart failure
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Insulin-requiring diabetes
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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)
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Preoperative anemia (hemoglobin <11g/dl for men and women)
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History of prior CABG
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Age ≥65
Exclusion Criteria
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Preexisting AKI within seven days before surgery as defined by KDIGO stage ≥1 (serum creatinine-based)
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Kidney transplant status
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Off-pump cardiac surgery
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ESRD
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Emergent cardiac surgery
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Pregnancy
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Patient enrolled in competing research studies that may affect outcomes
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Patients held in an institution by legal or official order
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Kaiser Permanente San Francisco Medical Center | San Francisco | California | United States | 94115 |
Sponsors and Collaborators
- Kaiser Permanente
- National Heart, Lung, and Blood Institute (NHLBI)
- Beth Israel Deaconess Medical Center
- Cedars-Sinai Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1620125