Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock?

Sepsis is the most common cause of acute kidney injury (AKI) in critically ill patients and is associated with a high mortality rate. Currently there is no available specific treatment to prevent or treat AKI in this setting. Many experimental and clinical data suggest that Nicotinamide, a safe and inexpensive vitamin, could be effective to prevent major adverse kidney events during septic shock. The main objective of the study is to show the superiority of Nicotinamide supplementation compared to the placebo group, in patients with septic shock admitted to intensive care. A 15% reduction in the incidence of major renal adverse events at day 30 is expected in the "Nicotinamide" group.

NCT Number	NCT04589546
Lead Sponsor	Centre Hospitalier Universitaire, Amiens Collaborators: Centre Hospitalier de Dieppe, Centre Hospitalier d'Abbeville, Centre Hospitalier de Laon, University Hospital, Caen, Centre Hospitalier de Cherbourg, University Hospital, Rouen, Centre Hospitalier de Roubaix, Centre Hospitalier de Bethune, Hôpital Saint Philibert, Lomme, Tourcoing Hospital, Centre Hospitalier de Valenciennes, Centre Hospitalier Arras, Centre Hospitalier de Lens, Centre Hospitalier de Calais
Conditions	Acute Kidney Injury, Septic Shock, Nicotinamide, Mortality
Enrollment	310 participants
Start Date	2020-10-01
Primary Completion	2025-09 (estimated)
Study Completion	2025-09 (estimated)
Updated on ClinicalTrials.gov	2025-08-24