Using L-carnitine to help septic shock patients with kidney injury

L-carnitine as an Adjunct Treatment for Septic Shock Patients With Acute Kidney Injury: a Multicentre, Randomized, 2-parallel Group, Superiority Trial

This study is testing if L-carnitine can help patients with septic shock and kidney injury live longer and feel better compared to those who get a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 272 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nīmes (Academic / other)
• Locations: 14 sites (Caen Cedex 9 and 13 other locations)
• Trial ID: NCT02664753 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of L-carnitine as an adjunct treatment for patients suffering from septic shock and acute kidney injury. It will compare the 28-day mortality rates between those receiving L-carnitine and those receiving a placebo. Additionally, the study will assess safety, nephrological outcomes, and the kinetics of serum carnitine levels over a 56-day treatment period. A biobank will also be established for future research related to kidney injury markers and carnitine response.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old admitted to intensive care for sepsis or septic shock with acute renal failure.

Not a fit: Patients who do not have acute renal insufficiency or are not experiencing septic shock may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce mortality rates in septic shock patients with acute kidney injury.

How similar studies have performed: While the use of L-carnitine in this context is relatively novel, previous studies have explored its potential benefits in other conditions, suggesting a promising avenue for further investigation.

Eligibility criteria

Inclusion Criteria:

* • The emergency inclusion procedure was correctly applied according to French law (signature of consent form by a patient-designated trusted person or a family member, or a medical decision to proceed with patient inclusion if the latter two persons are unavailable) ---- OR ---- signature of the consent form by the patient

  * The patient must be insured or beneficiary of a health insurance plan
  * The patient is at least 18 years old
  * The patient was admitted to an intensive care unit (participating in the study) for sepsis or septic shock and presented with acute renal failure requiring, at some point, the use of extra-renal purification.
  * • The patient has sepsis or septic shock according to international criteria SEPSIS 3 (Singer et al, The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) ; JAMA. 2016)
  * The patient has acute renal insufficiency with an KDIGO score of 3
  * The patient has started continuous renal replacement therapy (CRRT) or intermittent renal replacement therapy (IRRT) within the previous 72 hours, or will start RRT (CRRT or IRRT) within the next 72 hours.

Exclusion Criteria:

* • The patient is participating in, or has participated in over the past three months, another interventional study that may interfere with the results or conclusions of this study

  * The patient is in an exclusion period determined by a previous study
  * The patient is under judicial protection, or is an adult under guardianship
  * The patient is pregnant, parturient or breastfeeding
  * The patient is susceptible to procreate and does not use methods of effective contraception (contraceptive hormonal ring, surgical contraception, contraceptive implant, contraceptive pill, male or female sheaths, skin patch, intrauterine contraceptive device)
  * If the patient is unable to sign a consent form: the patient-designated trusted person or family member refuses to sign the consent form
  * If the patient is unable to sign a consent form: It is impossible to correctly inform the patient-designated trusted person or family member
  * The patient is able/apt to sign a consent form, but refuses to do so
  * The patient is able/apt to sign a consent form, but cannot be correctly informed
  * Septic shock without associated AKI
  * Patients with a known allergy to L-Carnitine or other component of levocarnil oral solution or for injection
  * Pre-existing chronic disease requiring dialysis
  * The patient has stage 4 CKD with baseline DFG (CDK) if known \<30 ml
  * History of seizures or epilepsy
  * Chronic bowel disease or history of chronic diarrhoea
  * Under treatment with sodium valproate

Where this trial is running

Caen Cedex 9 and 13 other locations

• CHU de Caen — Caen Cedex 9, France (Recruiting)
• CH de Chartres — Chartres, France (Recruiting)
• CHU de Clermont Ferrand — Clermont Ferrand, France (Recruiting)
• CHU de Dijon — Dijon, France (Recruiting)
• CHU Lyon — Lyon, France (Not_yet_recruiting)
• APHM - Hôpital Nord — Marseille Cedex 20, France (Withdrawn)
• APHM - Hôpital de la Conception — Marseille, France (Withdrawn)
• APHM - Hôpital de la Timone Adultes — Marseille, France (Withdrawn)
• CHU de Montpellier - St Eloi — Montpellier cedex 5, France (Recruiting)
• CHU de Montpellier - Lapeyronie — Montpellier, France (Recruiting)
• CHU de Nîmes - Hôpital Universitaire Carémeau — Nîmes Cedex 09, France (Recruiting)
• CHU de Poitiers — Poitiers Cedex, France (Recruiting)
• CHU de St Etienne — Saint-Priest en Jarez, France (Not_yet_recruiting)
• CHU de Toulouse - Hôpital Rangueil — Toulouse Cedex 9, France (Recruiting)

Study contacts

• Study coordinator: Pascal Reboul, MD

Conditions Severe Sepsis; Shock, Septic; Acute Kidney Injury