Active not recruitingPHASE3INTERVENTIONAL

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

Doctors are looking for new ways to protect the kidneys of very sick patients who have a serious condition called septic shock. Septic shock is a severe infection that can cause the kidneys to stop working properly, which is called acute kidney injury (AKI). There isn't a specific treatment right now to prevent or treat this kidney problem when it happens with septic shock. This study is looking at whether a common, affordable vitamin called Nicotinamide (a type of vitamin B3) can help. Scientists think it might reduce serious kidney problems in these patients. The study aims to see if taking Nicotinamide is better than a dummy treatment (placebo) at preventing important kidney issues within 30 days of being in intensive care with septic shock.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Centre Hospitalier Universitaire, Amiens

Enrolment target

310

Start

01 Oct 2020

Estimated completion

01 Sep 2025

Acute Kidney Injury Septic Shock Nicotinamide Mortality

What is this study about?

When someone has a very severe infection, their body can react in a dangerous way called septic shock. This can make them extremely unwell and often leads to problems with their kidneys, known as acute kidney injury (AKI). Unfortunately, AKI during septic shock is very serious and can be life-threatening. Right now, there isn't a specific medicine to prevent or treat this kidney damage.

Researchers are investigating whether a common and affordable vitamin, Nicotinamide (a form of vitamin B3), could help. Early research suggests that Nicotinamide might protect the kidneys. This study aims to find out if giving high doses of Nicotinamide to patients with septic shock can stop these serious kidney problems from happening.

This clinical trial is comparing Nicotinamide to a 'dummy' treatment (a placebo) in patients admitted to intensive care. The main goal is to see if Nicotinamide can reduce the number of serious kidney issues that occur within 30 days. Specifically, they hope to see a 15% reduction in these problems for patients taking Nicotinamide.

Key takeaways

This study investigates if vitamin B3 (Nicotinamide) can protect kidneys during septic shock.
Septic shock is a severe infection that can cause serious kidney problems.
Currently, there's no specific treatment to prevent kidney damage in this situation.
The study compares Nicotinamide to a dummy treatment (placebo).
It aims to reduce serious kidney problems within 30 days.
Only adults in intensive care with specific septic shock criteria can participate.

Who may be eligible?

This study is looking for adults (aged 18 or older) who are in intensive care with septic shock. This means they have a severe infection causing very low blood pressure that needs medication to keep it stable, and signs that their body isn't getting enough oxygen.

You wouldn't be able to join if you've had these septic shock symptoms for more than 24 hours, or if you immediately need kidney dialysis for certain severe conditions. Also, if you already have a very specific medical need for Nicotinamide, or if you have severe long-term kidney disease, or have had a kidney transplant, you can't take part.

Patients who are not expected to live beyond 24 hours or survive for 30 days due to other serious illnesses (like severe heart or lung failure, or advanced cancer) cannot participate. Pregnant or breastfeeding women, and those under legal guardianship, are also not eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult (18 years or older)?
Do you have septic shock and are in intensive care?
Have your septic shock symptoms started less than 24 hours ago?
Do you NOT already need immediate kidney dialysis?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you will be given either Nicotinamide or a placebo (a dummy treatment that looks the same) through a drip. You won't know which one you are getting. Doctors will closely monitor your kidney function and overall health throughout your time in intensive care and for up to 30 days. This will involve regular blood tests and checks to see how you are responding to treatment. The study will continue as long as you are in intensive care, and your health will be followed for 30 days after starting the treatment.

Potential risks and benefits

The potential benefit of this study is that Nicotinamide might help protect your kidneys during septic shock, potentially leading to better recovery. However, as with any medication, there's always a chance of side effects, although Nicotinamide is generally considered safe. You will be closely monitored for any reactions. Remember, taking part in a clinical trial is always voluntary, and you are free to withdraw at any time without affecting your medical care.

Locations (1)

CHU Amiens
Verified postcode
Amiens, France

Common questions

What is septic shock?

Septic shock is a very serious and life-threatening condition caused by your body's extreme reaction to an infection.

What is AKI?

AKI stands for Acute Kidney Injury. It means your kidneys suddenly stop working as well as they should.

What is Nicotinamide?

Nicotinamide is a form of vitamin B3. It's a common and generally safe vitamin.

What does 'placebo' mean?

A placebo is a dummy treatment that looks exactly like the real medication but doesn't contain the active drug.

How long does the study last?

The treatment will be given while you are in intensive care, and your health will be followed for 30 days from when you start the treatment.