Study on Nicotinamide for Preventing Kidney Problems in Septic Shock Patients

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What is this study about?

This clinical trial is focused on studying the effects of high-dose vitamin B3, also known as nicotinamide, in patients experiencing septic shock. Septic shock is a severe condition that occurs when an infection leads to dangerously low blood pressure and can cause major kidney problems. The study aims to determine if nicotinamide can help prevent serious kidney issues in these patients.

Participants in the study will receive either nicotinamide or a placebo. The treatment will be administered through an injection into the vein. The study will monitor the patients over a period of time to see if nicotinamide is more effective than the placebo in reducing the risk of major kidney events. These events include in-hospital mortality, the need for new renal replacement therapy, or ongoing kidney dysfunction.

The study will also look at other factors such as the length of hospital stay, the number of days patients live without needing kidney support, and any potential side effects like liver toxicity, nausea, or headaches. The goal is to gather information on whether nicotinamide can improve outcomes for patients with septic shock and reduce the incidence of kidney-related complications.

1 joining the study

Upon joining the study, the patient is confirmed to meet the inclusion criteria. This includes being an adult with septic shock, defined as sepsis with low blood pressure that requires medication to maintain a mean arterial pressure of at least 65 mm Hg, and having a serum lactate level greater than 2 mmol/L despite adequate fluid resuscitation.

2 initial assessment

The patient undergoes an initial assessment to establish baseline health metrics. This includes measuring serum creatinine levels to assess kidney function.

3 treatment administration

The patient receives treatment through intravenous administration. The medications used include sodium chloride solutions and nicotinamide.

The sodium chloride solutions are administered as a solution for infusion and injection. The specific products used are ‘CHLORURE DE SODIUM 0.9% AGUETTANT’ and ‘CHLORURE DE SODIUM FRESENIUS 0.9%’.

The nicotinamide is administered as a solution for injection, specifically ‘VITAMINE PP AGUETTANT 500 mg/5 ml’.

4 monitoring and follow-up

The patient’s health is monitored throughout the study. This includes checking for liver toxicity on days 1, 2, 3, and 7, and monitoring for symptoms such as nausea, vomiting, headache, flushing, and facial redness.

Kidney function is assessed by measuring serum creatinine levels on day 30 to determine if there is persistent renal dysfunction.

5 evaluation of outcomes

The primary outcome is the proportion of patients experiencing major adverse kidney events within 30 days, including in-hospital mortality, new renal replacement therapy, or persistent renal dysfunction.

Secondary outcomes include the reduction in the incidence of moderate to severe acute kidney injury, the number of days living without renal replacement therapy, and the length of hospital stay.

Who Can Join the Study?

Must be an adult patient. This means you need to be 18 years or older.
Must have septic shock. This is a serious condition where an infection leads to dangerously low blood pressure.
Must have persisting hypotension. This means your blood pressure stays low even after treatment.
Must require vasopressors. These are medications that help raise blood pressure.
Must have a MAP (mean arterial pressure) of 65 mm Hg or higher. This is a measure of the average blood pressure in your arteries.
Must have a serum lactate level greater than 2 mmol/L (18 mg/dL). This is a blood test that shows how much lactic acid is in your blood.
Must have received adequate volume resuscitation. This means you have been given enough fluids to try to raise your blood pressure.
Both male and female patients can participate.
Participants should not be from a vulnerable population. This means people who might need special protection or care are not included.

Who Cannot Join the Study?

Patients who have experienced adverse kidney events during a condition called septic shock cannot participate. Septic shock is a serious condition where an infection leads to dangerously low blood pressure and organ problems.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who do not belong to the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients.
Patients who are part of a vulnerable population are not eligible. Vulnerable populations include groups that may need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier De Tourcoing	Tourcoing	France
Centre Hospitalier Bethune Beuvry	Beuvry	France
Centre Hospitalier De Valenciennes	Valenciennes	France
Centre Hospitalier Public Du Cotentin	Cherbourg-En-Cotentin	France
Chorale Du Centre Hospitalier De Lens	Lens	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier de Dieppe	Dieppe	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Groupement Des Hopitaux De L’Institut Catholique De Lille	lomme	France
Czpobt Hpnixcpnjbn Dzitxlpeogljalmio	Abbeville	France
Civlgl Hijmtshusbx Dv Jyhw Eaju Tslfqk	Calais	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	14.06.2021

Trial locations

Investigated drugs:

Nicotinamide is being studied to see if it can help prevent major kidney problems in patients experiencing septic shock. This study is comparing the effects of Nicotinamide to a group not receiving the supplement, to determine if it offers any protective benefits for the kidneys during this critical condition.

Investigated diseases:

Septic shock

Septic Shock – A severe and widespread infection that leads to dangerously low blood pressure and organ dysfunction. It occurs when the body’s response to infection causes injury to its own tissues and organs. During septic shock, blood flow becomes insufficient to meet the body’s needs, leading to potential damage to vital organs. The condition can progress rapidly, requiring immediate medical attention to stabilize the patient. It is often associated with complications such as kidney injury and other organ failures. The progression of septic shock can vary, but it typically involves a critical need for intensive care support.

Trial ID:

2024-517055-13-00

Protocol code:

PI2020_843_0027

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Nicotinamide for Preventing Kidney Problems in Septic Shock Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?