NCT04589546

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

Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock? A Multicenter Randomized Controlled Study

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Kidney Injury
• Septic Shock
• Nicotinamide
• Mortality

Interventions

Type	Name	Description
DRUG	Nicotinamide treatment	Nicotinamide (500 mg) will be mixed in 50 ml of 0.9% saline and administered intravenously every 12 h for a total of 72 h.
DRUG	placebo treatment	For the placebo group, an identical volume of 0.9% saline will be administered in the same manner.

Timeline

• Start date: 2020-10-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2020-10-19
• Last updated: 2025-08-24

Locations

1 site across 1 country: France