Title

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
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Status

    Recruiting
  • Study Participants

    310
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.
Study Started
Oct 01
2020
Primary Completion
Oct 31
2023
Anticipated
Study Completion
Jan 31
2024
Anticipated
Last Update
Jul 21
2021

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.

Vitamin B3 Experimental

Placebo Placebo Comparator

Criteria

Inclusion Criteria:

Adult patients with septic shock defined as sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
Written informed consent

Exclusion Criteria:

Presence of inclusion criteria for more than 24 hours
Immediate indication to start renal replacement therapy at the time of randomization: Hyperkalemia≥ 6.5 mmol /l, metabolic acidosis with pH <7.15 not controlled by medical treatment, diuretic resistant acute pulmonary edema or accumulation of a toxic requiring dialysis.
Formal indication of Nicotinamide supplementation according to the attending physician (eg pellagra, undernutrition, severe alcoholism)
Known severe chronic kidney disease (clearance <30 ml /min) in the last 3 months preceding the setic shock or kidney transplant recipient.
Moribund patient (estimated survival less than 24 hours)
Patient who are not expected to survive to day 30 due to terminal-stage disease (terminal respiratory or heart failure, Child C cirrhosis, uncontrolled cancer)
Resuscitated cardiac arrest
Pregnant or lactating
Legal tutorship and guardianship
Lack of social security coverage.
No Results Posted