Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Does high-dose vitamin B3 supplementation prevent major adverse kidney events during septic shock? A multicenter randomized controlled study.

This research is investigating if giving a high dose of a specific vitamin B3 (nicotinamide) can protect the kidneys of adults who are extremely unwell due to a condition called septic shock. Septic shock can sometimes lead to serious kidney problems, including kidney failure. The study will compare patients receiving the vitamin B3 with those receiving a salt water solution (a placebo) to see if the vitamin reduces the number of patients who experience serious kidney issues like needing new kidney dialysis, long-lasting kidney problems, or even dying in the hospital. It's a large-scale study aiming to confirm if this treatment is effective and safe.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Enrolment target

310

Start

13 Sep 2024

adverse kidney events during septic shock

What is this study about?

When someone is very ill with a serious infection that causes their body to go into a life-threatening state called "septic shock," their organs, including the kidneys, can be severely affected. This study is looking into whether a high dose of a type of vitamin B3, called nicotinamide, could help protect the kidneys from damage in these very sick patients.

The main aim of the study is to see if taking this vitamin B3 can prevent some serious problems that can affect the kidneys. These problems include needing kidney dialysis for the first time, having long-term kidney issues, or even dying during their hospital stay. The researchers will compare how many patients experience these problems when given vitamin B3 versus when given a simple salt water solution (which acts as a stand-in treatment).

They will also be looking at other important things, like if the vitamin B3 can reduce lesser kidney problems, shorten hospital stays, or reduce the time spent in intensive care. The study will also carefully check for any side effects of the vitamin B3, like liver problems or feeling sick.

Key takeaways

This study is for adults with septic shock.
It tests if high-dose vitamin B3 can protect kidneys.
It aims to reduce serious kidney problems, dialysis, or death.
Patients receive either vitamin B3 or a salt water solution.
Potential side effects and kidney function are closely monitored.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older.

The study is open to both men and women.

The main requirement is that you have been diagnosed with septic shock and the doctors believe you could benefit from being part of this research, based on specific medical criteria they will check.

Quick self-check

Are you 18 years old or older?
Do you currently have septic shock?
Are you able to receive medication through a drip?
Are you willing for doctors to monitor your health closely during and after treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you are eligible and agree to take part, you would receive either the active study drug (high-dose vitamin B3) or a salt water solution (placebo) through a drip. This would happen while you are being treated for septic shock in the hospital. Doctors would closely monitor your health, especially your kidney function and any potential side effects like liver changes, nausea, headache, or skin flushing, on specific days (day 1, 2, 3, and 7).

Your recovery and kidney health would be followed for up to 30 days while you are in the hospital. The study would also track your kidney health and any major problems for up to 90 days after your initial treatment. All monitoring would be done as part of your standard hospital care, with additional specific checks related to the study.

Potential risks and benefits

Participating in this study might offer a potential benefit if vitamin B3 proves effective in protecting your kidneys during septic shock. However, there's no guarantee that it will help your specific condition. As with any medication, there are potential risks and side effects from the vitamin B3, which will be closely monitored, such as liver changes, feeling sick, headaches, or skin flushing. It's important to remember that you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

—
France

Common questions

What is septic shock?

Septic shock is a very serious and life-threatening condition caused by the body's overwhelming response to an infection, which can lead to organ damage.

What are "adverse kidney events"?

These are serious problems with the kidneys, like when they stop working properly and might need help from machines (dialysis) or suffer long-term damage.

What is vitamin B3 or Nicotinamide?

Nicotinamide is a form of vitamin B3 that is naturally found in food and essential for good health. In this study, it's being tested at a much higher dose than you'd get from food or supplements.

Is this a new medicine?

While vitamin B3 is common, using it at this high dose specifically to treat kidney problems during septic shock is investigational. This study is in Phase III, meaning it's a larger study to confirm if a promising treatment works.

Will I know if I'm getting vitamin B3 or the dummy treatment?

No, this is a 'blinded' study, meaning neither you nor your doctors will know whether you are receiving the vitamin B3 or the salt water solution. This helps ensure fair and accurate results.