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

Last updated: June 3, 2025
Sponsor: Centre Hospitalier Universitaire, Amiens
Overall Status: Active - Recruiting

Phase

3

Condition

Sepsis And Septicemia

Kidney Disease

Low Blood Pressure (Hypotension)

Treatment

Nicotinamide treatment

placebo treatment

Clinical Study ID

NCT04589546
PI2020_843_0027
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Adult patients with septic shock defined as sepsis with persisting hypotensionrequiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2mmol/L (18 mg/dL) despite adequate volume resuscitation.

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Presence of inclusion criteria for more than 24 hours

  • Immediate indication to start renal replacement therapy at the time ofrandomization: Hyperkalemia≥ 6.5 mmol /l, metabolic acidosis with pH <7.15 notcontrolled by medical treatment, diuretic resistant acute pulmonary edema oraccumulation of a toxic requiring dialysis.

  • Formal indication of Nicotinamide supplementation according to the attendingphysician (eg pellagra, undernutrition, severe alcoholism)

  • Known severe chronic kidney disease (clearance <30 ml /min) in the last 3 monthspreceding 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 Design

Total Participants: 310
Treatment Group(s): 2
Primary Treatment: Nicotinamide treatment
Phase: 3
Study Start date:
October 01, 2020
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • CHU Amiens

    Amiens, 80480
    France

    Active - Recruiting

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