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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT04589546

Collaborator

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

310

Enrollment

Location

Arms

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Septic Shock Nicotinamide Mortality	Drug: Nicotinamide treatment Drug: placebo treatment	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

310 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

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.

Placebo Comparator: Placebo

Drug: placebo treatment

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

Outcome Measures

Primary Outcome Measures

proportion of patients meeting one or more criteria for MAKE30 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT04589546

Other Study ID Numbers:

PI2020_843_0027

First Posted:

Oct 19, 2020

Last Update Posted:

Jul 21, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire, Amiens

Acute Kidney Injury

Septic Shock

Nicotinamide

Additional relevant MeSH terms:

Shock, Septic