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

NCT07739290 | Not Yet Recruiting

• 1 other identifier: 2025P000524
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Keywords

Acute kidney injury; nicotinamide adenine dinucleotide; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Post Operative day 1 urinary KIM-1

  Measurement of urinary KIM-1 pre-bypass and on post-operative day 1 compared via t-test.

  From enrollment to 1 day post cardiac surgery

Study Arms (2)

Intervention Group - Nicotinamide

EXPERIMENTAL

3000 mg nicotinamide administered the morning of surgery

Dietary Supplement: Nicotinamide (NAM)

Control

PLACEBO COMPARATOR

Placebo administered orally the morning of surgery

Dietary Supplement: Placebo control

Interventions

Nicotinamide (NAM) DIETARY_SUPPLEMENT

A one time 3000 mg nicotinamide dose administered orally on the morning of cardiac surgery

Intervention Group - Nicotinamide

Placebo control DIETARY_SUPPLEMENT

A visually identically placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• \. Conflict with other studies
• \. Previous usage of nicotinamide supplements in the past 30 days

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Mark J. Robitaille, MD

CONTACT

(617) 667-3112; mrobitai@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 31, 2026

Record last verified: 2026-07