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

Centre Hospitalier Universitaire, Amiens

Status and phase

Enrolling

Phase 3

Conditions

Mortality

Acute Kidney Injury

Nicotinamide

Septic Shock

Treatments

Drug: placebo treatment

Drug: Nicotinamide treatment

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT04589546

PI2020_843_0027

Details and patient eligibility

About

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.

Enrollment

310 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.