NAD Supplementation to Reduce the Incidence of Cardiac Surgery Associated Acute Kidney Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nicotinamide (NAM), Placebo control.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The purpose of this single-center, randomized, double-blinded placebo-controlled pilot trial is to demonstrate feasibility and help design a larger trial to assess the effectiveness of nicotinamide (NAM) supplementation in reducing risk of post-operative AKI in patients undergoing cardiac surgery.
Detailed description
This single-center, randomized, double-blind, placebo-controlled trial will serve as a pilot for a larger study that aims to assess the efficacy of nicotinamide in reducing ischemia-reperfusion injury and acute kidney injury (AKI) in patients undergoing cardiac surgery. A total of 20 patients will be randomized in a 1:1 ratio to receive either a one-time dose of NAM 3000 mg or a matching placebo on the morning of surgery. Safety assessments and clinical outcomes will be monitored for 2 days (\> 5 half-lives) . Blood samples will be collected from patients at up to two time points: preoperatively (after insertion of an arterial line \[for blood\] and intraoperatively at the end of CPB. Urine samples will also be collected at two timepoints: after insertion of the foley catheter but prior to incision, and on the morning of post-operative day 1. Discarded tissue specimens will be collected from patients at two time points: initially when excised pre-bypass, and another post-bypass, depending on the tissue availability and as a regular part of the surgery. Time points will be recorded for all the collections.
Interventions
- Dietary supplement Nicotinamide (NAM)
A one time 3000 mg nicotinamide dose administered orally on the morning of cardiac surgery - Dietary supplement Placebo control
A visually identically placebo
Primary outcome measures
- Post Operative day 1 urinary KIM-1 [Time frame: From enrollment to 1 day post cardiac surgery]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Undergoing coronary artery bypass graft (CABG) and/or valve surgery with cardiopulmonary bypass (CPB) at BIDMC. Includes combination surgeries that involve CABG and/or valve plus other procedures (e.g., Maze procedure, aortic aneurysm repair).
- AKI risk score ≥6 at the time of screening
Exclusion criteria
- History of AKI in the seven days prior to surgery, defined as any of the following:
- Increase in serum creatinine ≥0.3 mg/dl in 48h
- Increase in serum creatinine ≥50% in 7d (if no value available in last 7d, use most recent value in last 3 months)
- Urine output ≤0.5 ml/kg/h x 6 consecutive hours (only assessed in patients with hourly monitoring via Foley catheter)
- Receipt of renal replacement therapy (RRT) within 7d
- Advanced chronic kidney disease (eGFR <15 ml/min/1.73m2 or end-stage kidney disease receiving RRT)
- Pregnant or breastfeeding\*
- Positive COVID test in the last 10 days.
- Prisoner or institutionalized
- Existing or anticipated durable VAD
8\. Conflict with other studies
9\. Previous usage of nicotinamide supplements in the past 30 days
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07739290 · 2025P000524