Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521307
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Impact of Nicotinamide Riboside NR on Kidney Function in Patients Undergoing Cardiac Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Nicotinamide Riboside NR on Kidney Function in Patients Undergoing Cardiac SurgeryA Randomized Controlled Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AKI-RCT
Brief Summary:
Acute kidney injury AKI associated with cardiac surgery is the most important complication in adult patients undergoing open heart surgery and is associated with increased mortality and morbidity In patients in intensive care units it is the second most common type of AKI after AKI secondary to sepsis There is currently no specific treatment for AKI Supportive measures include renal support therapy for patients with severe AKI and mortality in this subgroup of patients exceeds 50 Increasing NAD with niacinamide has been shown to prevent various etiologies of experimental AKI in mice and an early pilot study has shown both increased NAD levels following administration of nicotinamide riboside with pterostilbene NPRT and the safety of niacinamide in patients undergoing cardiac surgery
Detailed Description:
AKI associated with cardiac surgery is a condition with a high incidence of morbidity and mortality without pharmacological interventions approved for its prevention or treatment As far as we know there is no study that evaluates the impact of the administration of nicotinamide riboside on renal function in patients undergoing cardiac surgery
Implementation of this relatively low-cost intervention and adequate safety profile would reduce in-hospital complications in risk patients undergoing cardiac surgery
Nicotinamide adenine dinucleotide NAD is a cellular factor related to metabolism and longevity NAD is a required cofactor of SIRT1 a nuclear deacetylase that modulates chromatin structure gene expression prolongs lifespan in organisms and ameliorates age-related diseases Experimental AKI in mice rapidly leads to reduced NAD levels in the kidney resulting from a combination of decreased NAD biosynthesis and increased NAD consumption Likewise mice deficient in SIRT1 are more susceptible to AKI and when there is overexpression of SIRT1 they are protected from AKI These studies describe the modulation of NAD and SIRT1 as a potential therapeutic approach in AKI Similarly in subjects with AKI there is evidence of a 50 reduction in plasma NAD Increasing NAD with niacinamide has been shown to prevent various etiologies of experimental AKI in mice and an early pilot study has shown both increased NAD levels following administration of nicotinamide riboside with pterostilbene NPRT and the safety of niacinamide in patients undergoing cardiac surgery
Implementation of this relatively low-cost intervention and adequate safety profile would reduce in-hospital complications in risk patients undergoing cardiac surgery
Nicotinamide adenine dinucleotide NAD is a cellular factor related to metabolism and longevity NAD is a required cofactor of SIRT1 a nuclear deacetylase that modulates chromatin structure gene expression prolongs lifespan in organisms and ameliorates age-related diseases Experimental AKI in mice rapidly leads to reduced NAD levels in the kidney resulting from a combination of decreased NAD biosynthesis and increased NAD consumption Likewise mice deficient in SIRT1 are more susceptible to AKI and when there is overexpression of SIRT1 they are protected from AKI These studies describe the modulation of NAD and SIRT1 as a potential therapeutic approach in AKI Similarly in subjects with AKI there is evidence of a 50 reduction in plasma NAD Increasing NAD with niacinamide has been shown to prevent various etiologies of experimental AKI in mice and an early pilot study has shown both increased NAD levels following administration of nicotinamide riboside with pterostilbene NPRT and the safety of niacinamide in patients undergoing cardiac surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None