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

Primary Purpose

Acute Kidney Injury, Septic Shock, Nicotinamide

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Nicotinamide treatment
placebo treatment
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Acute Kidney Injury, Septic Shock, Nicotinamide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin B3

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 14, 2020
Last Updated
December 8, 2022
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Centre Hospitalier de Dieppe, Centre Hospitalier d'Abbeville, Centre Hospitalier de Laon, University Hospital, Caen, Centre Hospitalier de Cherbourg, University Hospital, Rouen, Centre Hospitalier de Roubaix, Centre Hospitalier de Bethune, Hôpital Saint Philibert, Lomme, Tourcoing Hospital, Centre Hospitalier de Valenciennes, Centre Hospitalier Arras, Centre Hospitalier de Lens, Centre Hospitalier de Calais
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1. Study Identification

Unique Protocol Identification Number
NCT04589546
Brief Title
Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock?
Acronym
VITAKI
Official Title
Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock? A Multicenter Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Centre Hospitalier de Dieppe, Centre Hospitalier d'Abbeville, Centre Hospitalier de Laon, University Hospital, Caen, Centre Hospitalier de Cherbourg, University Hospital, Rouen, Centre Hospitalier de Roubaix, Centre Hospitalier de Bethune, Hôpital Saint Philibert, Lomme, Tourcoing Hospital, Centre Hospitalier de Valenciennes, Centre Hospitalier Arras, Centre Hospitalier de Lens, Centre Hospitalier de Calais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Septic Shock, Nicotinamide, Mortality
Keywords
Acute Kidney Injury, Septic Shock, Nicotinamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin B3
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nicotinamide treatment
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo treatment
Intervention Description
For the placebo group, an identical volume of 0.9% saline will be administered in the same manner.
Primary Outcome Measure Information:
Title
proportion of patients meeting one or more criteria for MAKE30
Description
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
Time Frame
3 years after study start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitri Titeca-Beauport, MD
Phone
0322456411
Email
dimitri.titeca@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitri Titeca-Beauport, MD
Phone
0322456411
Email
dimitri.titeca@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Pierre-Louis DECLERCQ, MD
First Name & Middle Initial & Last Name & Degree
Hervé DUPONT, MD
First Name & Middle Initial & Last Name & Degree
Antoine RIVIERE, MD
First Name & Middle Initial & Last Name & Degree
Eloi GOULLIEUX, MD
First Name & Middle Initial & Last Name & Degree
Damien DUCHEYRON, MD
First Name & Middle Initial & Last Name & Degree
Bertrand SAUNEUF, MD
First Name & Middle Initial & Last Name & Degree
Steven GRANGE, MD
First Name & Middle Initial & Last Name & Degree
Patrick HERBECQ, MD
First Name & Middle Initial & Last Name & Degree
Christophe VINSONNEAU, MD
First Name & Middle Initial & Last Name & Degree
Thierry VAN DER LINDEN, MD
First Name & Middle Initial & Last Name & Degree
Olivier LEROY, MD
First Name & Middle Initial & Last Name & Degree
Maxime GRANIER, MD
First Name & Middle Initial & Last Name & Degree
Didier THEVENIN, MD
First Name & Middle Initial & Last Name & Degree
Joseph Bayekula, MD
First Name & Middle Initial & Last Name & Degree
Julien Maizel, Pr
First Name & Middle Initial & Last Name & Degree
Fabien LAMBIOTTE, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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