Informations générales (source: ClinicalTrials.gov)
Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock? A Multicenter Randomized Controlled Study (VITAKI)
Interventional
Phase 3
Centre Hospitalier Universitaire, Amiens (Voir sur ClinicalTrials)
octobre 2020
juillet 2025
04 juillet 2025
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Amiens - 80480 - Amiens - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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.