Study on L-Carnitine and Cobamamide for Patients with Septic Shock and Acute Kidney Injury

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for patients experiencing septic shock with acute kidney injury. Septic shock is a severe infection that leads to dangerously low blood pressure and can cause multiple organ failures, including the kidneys. Acute kidney injury is a sudden episode of kidney failure or damage that happens within a few hours or days. The treatment being tested involves the use of L-Carnitine, a substance that is naturally found in the body and helps turn fat into energy. In this study, L-Carnitine is used as an additional treatment to see if it can improve outcomes for patients with septic shock and acute kidney injury.

The purpose of the study is to compare the survival rates over 28 days between patients receiving L-Carnitine and those who do not. Participants in the study will be randomly assigned to one of two groups: one group will receive L-Carnitine along with their standard treatment, while the other group will receive the standard treatment without L-Carnitine. Some participants may receive a placebo instead of L-Carnitine. The study will monitor various health outcomes, such as the number of days patients are alive without needing kidney support, mechanical ventilation, or intensive care.

The study will last for a period of time, during which participants will be closely monitored by healthcare professionals. The goal is to determine if adding L-Carnitine to the treatment plan can help improve survival and recovery in patients with septic shock and acute kidney injury. This research could provide valuable insights into better treatment options for these serious conditions.

1 joining the study

The patient is included in the study after meeting specific criteria, such as being at least 18 years old, having sepsis or septic shock, and experiencing acute kidney injury.

Consent is obtained either from the patient or a designated trusted person or family member.

2 initial assessment

The patient’s condition is evaluated to confirm eligibility, including the need for renal replacement therapy within a specified timeframe.

3 treatment administration

The patient receives levocarnitine as an adjunct treatment. This is administered intravenously as a solution for injection or infusion.

The dosage and frequency are determined by the medical team based on the patient’s condition.

4 monitoring and follow-up

The patient’s vital signs and response to treatment are closely monitored throughout the study.

Regular assessments are conducted to track progress, including days alive without renal failure or other organ failures.

5 completion of the study

The study aims to compare the 28-day mortality rates between patients receiving levocarnitine and those who do not.

The study is expected to conclude by May 2026, with data collected on survival and other health outcomes.

Who Can Join the Study?

The emergency inclusion procedure was correctly applied according to French law. This means either a trusted person or family member signed the consent form, or a medical decision was made to include the patient if those people were unavailable. Alternatively, the patient themselves signed the consent form.
The patient must have health insurance or be a beneficiary of a health insurance plan.
The patient is at least 18 years old.
The patient was admitted to an intensive care unit for sepsis or septic shock and had acute renal failure that required the use of a special treatment to clean the blood, known as extra-renal purification.
The patient has sepsis or septic shock according to international criteria called SEPSIS 3.
The patient has acute renal insufficiency with a KDIGO score of 3. This score is a way to measure how severe the kidney problem is.
The patient has started or will start a treatment called renal replacement therapy (RRT), which can be continuous (CRRT) or intermittent (IRRT), within a 72-hour period.

Who Cannot Join the Study?

Patients who are not experiencing septic shock. Septic shock is a serious condition that happens when an infection leads to very low blood pressure.
Patients without acute renal insufficiency. This means the kidneys are not working properly, and it happens suddenly.
Patients who are not within the specified age range. The study is looking for certain age groups.
Patients who are not part of the specified clinical trial groups. The study is targeting specific groups of patients.
Patients who are not male or female. The study includes both genders.
Patients who are not considered part of a vulnerable population. Vulnerable populations may include groups like children, elderly, or those with certain health conditions.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nimes	Nimes	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	05.03.2018

Trial locations

Investigated drugs:

L-Carnitine is being studied as an additional treatment for patients experiencing septic shock with acute kidney injury. The trial aims to determine if adding L-Carnitine to the standard treatment can improve survival rates over 28 days. L-Carnitine is a substance that helps the body produce energy and is thought to have potential benefits in supporting kidney function and overall recovery in critically ill patients.

Septic Shock – Septic shock is a severe and widespread infection that leads to dangerously low blood pressure and abnormalities in cellular metabolism. It occurs when an infection in the body triggers an extreme immune response, causing inflammation and blood clotting throughout the body. This can result in a significant drop in blood pressure, reducing blood flow to vital organs and potentially leading to organ failure. The condition progresses rapidly and requires immediate medical attention to prevent further complications. It is often associated with acute renal insufficiency, where the kidneys fail to filter waste from the blood effectively. The progression of septic shock can lead to multiple organ dysfunction if not managed promptly.

Trial ID:

2024-512508-21-00

NCT ID:

NCT02664753

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on L-Carnitine and Cobamamide for Patients with Septic Shock and Acute Kidney Injury

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?