NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaiser Permanente
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
CABG
Aortic, mitral, tricuspid, or pulmonic valve replacement or repair
Disqualifiers
Preexisting AKI within seven days before surgery as defined by KDIGO stage ≥1 (serum creatinine-based)
Kidney transplant status
Off-pump cardiac surgery
ESRD
Trial design
Design model
Parallel
Treatments tested in this trial
Niacinamide
DrugNiacinamide 3 grams on the day of surgery and post-surgical days one and two
Placebo
DrugMatched placebo on the day of surgery and post-surgical days one and two
Treatment groups
304 Participants
are divided into 2 treatment groupsGroup A: Oral niacinamideExperimental treatment 1 intervention
Group B: Matched placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Troponin T AUC
Troponin T AUC, composed of single daily serum measurements
Time frame
From baseline to three days after surgerySecondary outcomes
1
Mean difference in uQuin/Tryp ratio AUC
Mean difference in uQuin/Tryp ratio AUC composed of single daily serum measurements
Time frame
From baseline to three days after surgery2
Mean difference in eGFR
Mean difference in eGFR (CKD-EPI formula)
Time frame
From baseline through day 5.Other outcomes
1
Number of Participants with the following Adverse Events and Serious Adverse Events
* 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)
Time frame
From baseline through day 902
Length of index hospital stay.
• Mean length of index hospital stay (days)
Time frame
From baseline through day 903
Length of intensive care unit stay.
• Mean length of intensive care unit stay (days)
Time frame
From baseline through day 904
Perioperative inotropic-score and vasoactive-inotropic score.
• Mean inotropic-score and vasoactive-inotropic score
Time frame
At 6, 12, 24, and 48 hours post operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Kaiser Permanente
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
Cedars-Sinai Medical Center
Collaborator
Source ClinicalTrials.gov