drugset / Trial / NCT04589546
Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock?
Phase 3
Active not recruiting
310 enrolled
Centre Hospitalier Universitaire, Amiens
Centre Hospitalier Arras · collabCentre Hospitalier d'Abbeville · collabCentre Hospitalier de Bethune · collabCentre Hospitalier de Calais · collabCentre Hospitalier de Cherbourg · collabCentre Hospitalier de Dieppe · collabCentre Hospitalier de Laon · collabCentre Hospitalier de Lens · collabCentre Hospitalier de Roubaix · collabCentre Hospitalier de Valenciennes · collabHôpital Saint Philibert, Lomme · collabTourcoing Hospital · collabUniversity Hospital, Caen · collabUniversity Hospital, Rouen · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2020-10-01
- Primary completion
- 2025-09
- Completion
- 2025-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicotinamide | Other / unclassified | 500 mg | Intravenous |