Acute Kidney Injury
Conditions
Brief summary
This is a single center, randomized, single-blind, placebo-controlled study to evaluate the safety and biochemical effects of niacinamide on metabolic parameters of the kidney in patients undergoing cardiac surgery.
Interventions
DRUGOral niacinamide, 1 gram daily
DRUGOral niacinamide, 3 gram daily
DRUGPlacebo
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. All patients undergoing cardiac surgery with the use of cardiopulmonary bypass at high risk for acute kidney injury. A Cleveland score of 6 or more is used to define patients at high risk for acute kidney injury 2. Age ≥ 18 3. Signed informed consent
Exclusion criteria
1. Pre-existing acute kidney injury 2. Kidney transplantation 3. Off-pump heart surgery 4. Pregnancy 5. End stage renal disease 6. Pregnancy (female subjects of childbearing potential must have a negative serum pregnancy test) 7. Subjects with any kind of dependency on the investigator (e.g. any subject who is under direct supervision of the investigator/co-investigators or employed by the investigator/co-investigators) 8 Subjects held in an institution by legal or official order (e.g. subjects in jail, prison, juvenile offender facility, or treatment facility including those who are in hospitals, alcohol, and drug treatment facilities under court order, and individuals with psychiatric illnesses who have been committed involuntarily to an institution)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in serum metabolite profile of niacinamide | Baseline and days 1 through 4 |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in urine metabolite profile of niacinamide | Baseline and days 1 through 4 |
Other
| Measure | Time frame |
|---|---|
| Adverse events | From enrollment through day 4, and at day 30 |
Countries
United States
Outcome results
None listed