Clinical trial NCT04589546: Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock?
Official title: Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock? A Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Kidney Injury
Septic Shock
Nicotinamide
Mortality
Keywords: Acute Kidney Injury
Septic Shock
Nicotinamide
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier de Dieppe
name: Centre Hospitalier d'Abbeville
name: Centre Hospitalier de Laon
name: University Hospital, Caen
name: Centre Hospitalier de Cherbourg
name: University Hospital, Rouen
name: Centre Hospitalier de Roubaix
name: Centre Hospitalier de Bethune
name: Hôpital Saint Philibert, Lomme
name: Tourcoing Hospital
name: Centre Hospitalier de Valenciennes
name: Centre Hospitalier Arras
name: Centre Hospitalier de Lens
name: Centre Hospitalier de Calais
First posted: 2020-10-19
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: proportion of patients meeting one or more criteria for MAKE30
timeFrame: 3 years after study start
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References: