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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
304
Niacinamide 3 grams on the day of surgery and post-surgical days one and two
Matched placebo on the day of surgery and post-surgical days one and two
Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States
RECRUITINGTroponin T AUC
Troponin T AUC, composed of single daily serum measurements
Time frame: From baseline to three days after surgery
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 surgery
Mean difference in eGFR
Mean difference in eGFR (CKD-EPI formula)
Time frame: From baseline through day 5.
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