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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Molecular Effects of Vitamin B3 (Niacinamide) in Acute Kidney Injury

NCT02701127

Acute Kidney Injury

COMPLETED EARLY_PHASE1

Efficacy and Safety of N-Acetylcysteine Versus Alpha-Lipoic Acid in Colistin-Induced Nephrotoxicity

NCT06650384

Nephrotoxicity

RECRUITING PHASE2/PHASE3

The Use of Inorganic Nitrate for the Prevention of Contrast-induced Nephropathy

NCT03627130

Contrast-induced Nephropathy Acute Kidney Injury Acute Coronary Syndrome

COMPLETED PHASE2

Protection From Acute Kidney Injury (AKI) With Basis™ Treatment

NCT04342975

AKI

COMPLETED PHASE2

N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity

NCT00267384

Drug Induced Nephrotoxicity

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Kidney Injury Septic Shock Nicotinamide Mortality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin B3

Group Type EXPERIMENTAL

Nicotinamide treatment

Intervention Type 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.

Placebo

Group Type PLACEBO_COMPARATOR

placebo treatment

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

placebo treatment

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No