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

NCT04589546 | Active Not Recruiting Phase 3

• 1 other identifier: PI2020_843_0027
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Septic Shock; Nicotinamide; Mortality

Keywords

Acute Kidney Injury; Septic Shock; Nicotinamide

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vitamin B3

EXPERIMENTAL

Drug: Nicotinamide treatment

Placebo

PLACEBO COMPARATOR

Drug: placebo treatment

Interventions

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.

Vitamin B3

placebo treatment DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Acute Kidney Injury; Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 19, 2020
• Study Start: October 1, 2020
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)