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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Mortality; Septic Shock; Acute Kidney Injury; Nicotinamide
• Intervention / Treatment: Drug: Nicotinamide treatment; Drug: placebo treatment

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80480
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo treatment; For the placebo group, an identical volume of 0.9% saline will be administered in the same manner.
Experimental: Vitamin B3	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of patients meeting one or more criteria for MAKE30	MAKE30 is : in-hospital mortality, receipt of new RRT, or persistent renal dysfunction defined as a final inpatient serum creatinine value ≥2 time baseline serum creatinine	3 years after study start

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: University Hospital, Rouen; University Hospital, Caen; Tourcoing Hospital; Centre Hospitalier Arras; Centre Hospitalier de Roubaix; Centre Hospitalier de Dieppe; Centre Hospitalier d'Abbeville; Centre Hospitalier de Laon; Centre Hospitalier de Cherbourg; Centre Hospitalier de Bethune; Hôpital Saint Philibert, Lomme; Centre Hospitalier de Valenciennes; Centre Hospitalier de Lens; Centre Hospitalier de Calais

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Septic Shock; Acute Kidney Injury; Nicotinamide
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Acute Kidney Injury; Shock; Shock, Septic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Micronutrients; Vitamin B Complex; Vitamins; Vasodilator Agents; Hypolipidemic Agents; Lipid Regulating Agents; Niacin; Niacinamide; Nicotinic Acids
• Other Study ID Numbers: PI2020_843_0027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No