NAD Supplementation to Reduce the Incidence of Cardiac Surgery Associated Acute Kidney Injury | NCT07739290

NCT07739290

Overview

NCT ID: NCT07739290
Lead Sponsor: Beth Israel Deaconess Medical CenterOTHER
Official Title: NAD Supplementation to Reduce the Incidence of Cardiac Surgery Associated Acute Kidney Injury
Brief Summary: 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.
Conditions: Acute Kidney Injury
Interventions: Nicotinamide (NAM)
Placebo control

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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

Central Contacts: Mark J. Robitaille, MDContact
mrobitai@bidmc.harvard.edu(617) 667-3112