Acute Kidney Injury
Conditions
Keywords
Acute kidney injury, nicotinamide adenine dinucleotide, cardiac surgery
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.
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_SUPPLEMENTNicotinamide (NAM)
A one time 3000 mg nicotinamide dose administered orally on the morning of cardiac surgery
DIETARY_SUPPLEMENTPlacebo control
A visually identically placebo
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. 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). 3. AKI risk score ≥6 at the time of screening
Exclusion criteria
1. 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 2. Advanced chronic kidney disease (eGFR \<15 ml/min/1.73m2 or end-stage kidney disease receiving RRT) 3. Pregnant or breastfeeding\* 4. Positive COVID test in the last 10 days. 5. Prisoner or institutionalized 6. Existing or anticipated durable VAD 8\. Conflict with other studies 9\. Previous usage of nicotinamide supplements in the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative day 1 urinary KIM-1 | From enrollment to 1 day post cardiac surgery | Measurement of urinary KIM-1 pre-bypass and on post-operative day 1 compared via t-test. |
Contacts
CONTACTMark J. Robitaille, MD
Outcome results
None listed