L-carnitine as an Adjunct Treatment for Septic Shock Patients With Acute Kidney Injury (CarniSave)

  • End date
    Apr 16, 2025
  • participants needed
  • sponsor
    Centre Hospitalier Universitaire de Nīmes
Updated on 16 March 2022
severe sepsis
renal replacement therapy
septic shock


The primary objective of this study is to compare 28 day mortality rates between septic shock patients with acute renal insufficiency treated via L-Carnitine (as an adjunct therapy) versus a similar group of patients not receiving L-Carnitine adjunct therapy.


The secondary objectives of this study are:

  1. First secondary objective of this study is to compare 10 day mortality rates of septic shock patients with renal insufficiency treated via L-Carnitine (as an adjunct therapy) for 56 days versus a patients not receiving L-Carnitine adjunct therapy
  2. To compare study arms in terms of patient safety.
  3. To compare study arms in terms of further clinical outcomes, with special emphasis on nephrological outcomes.
  4. To study (and compare between arms) the kinetic curves of free and total serum carnitine. Renal replacement therapy rapidly depletes the body's carnitine levels. Tracking adequate carnitine levels is therefore important for the interpretation of study results.
  5. To constitute a bio-bank in association with the study for future ancillary studies (e.g. kidney injury marker studies, carnitine-responders versus non-responders, and other exploratory studies.

Condition Severe Sepsis, Shock, Septic, Acute Kidney Injury
Treatment 56 days of weight-adjusted L-Carnitine treatment, 10 days of intravenous placebo (isotonic saline)
Clinical Study IdentifierNCT02664753
SponsorCentre Hospitalier Universitaire de Nīmes
Last Modified on16 March 2022


Yes No Not Sure

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 has been admitted to a participating ICU for severe sepsis or septic shock within the last 72 hours
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 past 24 hours, or will start RRT (CRRT or IRRT) within the next 24 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
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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note