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NCT Number: NCT04589546

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Mortality Nicotinamide Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens

Amiens, 80480, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotinamide treatment

Drug

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.

placebo treatment

Drug

For the placebo group, an identical volume of 0.9% saline will be administered in the same manner.

Primary outcomes

  1. proportion of patients meeting one or more criteria for MAKE30

    Time frame: 3 years after study start

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

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

Registry information

Official study title

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

Acronym: VITAKI

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 19, 2020
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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