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

Acute Kidney Injury Clinical Trial

— VITAKI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04589546
• Other study ID #: PI2020_843_0027
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2020
• Est. completion date: January 2024

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Dimitri Titeca-Beauport, MD
• Phone: 0322456411
• Email: dimitri.titeca[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: January 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Mortality
• Nicotinamide
• Septic Shock
• Shock
• Shock, Septic

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (15)

Lead Sponsor

Collaborator

Centre Hospitalier Universitaire, Amiens

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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