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Severe SepsisPhase 3CarniSaveNCT02664753

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

A Phase 3 study testing 56 days of weight-adjusted L-Carnitine treatment in people with Severe Sepsis and Shock, Septic, run by Centre Hospitalier Universitaire de Nīmes at 11 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Sepsis, Shock, Septic, Acute Kidney Injury
What is being tested?
56 days of weight-adjusted L-Carnitine treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
254 participants
Where
11 sitesFrance
Study dates
5 Mar 2018to 4 Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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.

Who cannot join

  • • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • CHU de Caen

    Caen, 14033

  • CH de Chartres

    Chartres

  • CHU de Clermont Ferrand

    Clermont-Ferrand, 63003

  • CHU de Dijon

    Dijon, 21079

  • CHU Lyon

    Lyon

  • CHU de Montpellier - Lapeyronie

    Montpellier, 34295

  • CHU de Montpellier - St Eloi

    Montpellier, 34295

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

  • CHU de Poitiers

    Poitiers, 86021

  • CHU de St Etienne

    Saint-Priest-en-Jarez, 42270

  • CHU de Toulouse - Hôpital Rangueil

    Toulouse, 31059 T

Other trials in France

About this study

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

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.

Read the detailed description

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.
Being tested
56 days of weight-adjusted L-Carnitine treatment, 10 days of intravenous placebo (isotonic saline)
Medical subject headings
Sepsis, Shock, Septic, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 56 days of weight-adjusted L-Carnitine treatmentDrug

    Patients in the experimental arm will receive 10 days of intravenous L-carnitine treatment followed by 46 days of oral L-Carnitine treatment.

    Day 1: a first bolus of 6g of L-Carnitine is administered with a syringe driver of 50 ml.

    Day 2 to Day 10: Two mini-perfusions are prepared each day, corresponding to 1 administration every 12 hours. 50 mg/kg/day (rounded up to the next gram) L-Carnitine is added to each syringes

    For the next 46 days, patients will take oral doses of L-Carnitine as follows:

    < à 60kg : 2g/day > 60kg : 3g/day If the patient leaves the hospital before D10, oral treatment can be initiated at the end of the hospitalization

  • 10 days of intravenous placebo (isotonic saline)Drug

    Patients in the placebo arm will receive 10 days of intravenous isotonic saline in a fashion analogous to the experimental arm (they study is thus blinded for the first 10 days and then open there afterwards).

    Day 1: 1 50ml syringe driver of 50 ml isotonic saline solution . Day 2 to Day 10 : Two syringe drivers of 50 ml of isotonic saline solution are prepared each day, one during the morning and one during the evening.

Study groups in NCT02664753
Study groupRoleWhat they receive
L-Carnitine groupExperimentalPatients in the experimental arm will receive 10 days of intravenous L-carnitine treatment followed by 46 days of oral L-Carnitine treatment. Intervention: 56 days of weight-adjusted L-Carnitine treatment
Receives: Drug: 56 days of weight-adjusted L-Carnitine treatment
Placebo then open groupPlacebo comparatorPatients in the placebo arm will receive 10 days of intravenous isotonic saline in a fashion analogous to the experimental arm (they study is thus blinded for the first 10 days and then open there afterwards). Intervention: 10 days of intravenous placebo (isotonic saline)
Receives: Drug: 10 days of intravenous placebo (isotonic saline)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Measured: 28 days

Secondary outcomes (33)

  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.

    Mortality

    Measured: 10 days

  2. Adverse Events per patient

    Measured: 12 months (throughout study)

  3. Survival

    Measured: 12 months (throughout study)

  4. The number of days alive and not on renal replacement therapy

    Measured: 12 months

  5. The number of days alive and free of renal failure

    Measured: 12 months

  6. The number of days alive and free of organ failure

    Measured: 12 months

  7. The number of days alive and not on mechanical ventilation

    Measured: 12 months

  8. The number of days alive and not in Intensive Care Unit (ICU)

    Measured: 12 months

  9. The number of days alive and not in hospital

    Measured: 12 months

  10. The number of days alive and free of (not requiring) catecholamines

    Measured: 12 months

  11. A vector of repeated measures of daily SOFA (Sequential Organ Failure Assessment score) scores available during the ICU stay

    Available daily scores will be aggregated into a vector for repeated measures analysis (similar to the agregation required for calculating a slope).

    Measured: at ICU discharge (expected max of 28 days)

  12. A vector of repeated measures of AKIN (Acute Kidney Injury Network score) score available during the ICU stay

    Available daily scores will be aggregated into a vector for repeated measures analysis (similar to the agregation required for calculating a slope).

    Measured: at ICU discharge (expected max of 28 days)

  13. A vector of repeated measures of serum creatinine

    Available measures will be aggregated into a vector for repeated measures analysis (similar to the agregation required for calculating a slope).

    Measured: at ICU discharge (expected max of 28 days)

  14. A vector of repeated measures of serum creatinine

    Available measures will be aggregated into a vector for repeated measures analysis (similar to the agregation required for calculating a slope).

    Measured: at discharge from the nephrology department (expected max of 60 days)

  15. A vector of repeated measures of lactate levels available during the ICU stay

    Available measures will be aggregated into a vector for repeated measures analysis (similar to the agregation required for calculating a slope).

    Measured: at ICU discharge (expected max of 28 days)

  16. Glomerular filtration rate (EpiCKD)

    (if the patient is on dialysis, the glomerular filtration rate is set at 0)

    Measured: month 1

  17. Glomerular filtration rate (EpiCKD)

    (if the patient is on dialysis, the glomerular filtration rate is set at 0)

    Measured: month 2

  18. Glomerular filtration rate (EpiCKD)

    (if the patient is on dialysis, the glomerular filtration rate is set at 0)

    Measured: month 3

  19. Glomerular filtration rate (EpiCKD)

    (if the patient is on dialysis, the glomerular filtration rate is set at 0)

    Measured: month 6

  20. Glomerular filtration rate (EpiCKD)

    (if the patient is on dialysis, the glomerular filtration rate is set at 0)

    Measured: month 9

  21. Glomerular filtration rate (EpiCKD)

    (if the patient is on dialysis, the glomerular filtration rate is set at 0)

    Measured: month 12

  22. Serum free carnitine level

    Measured: baseline

  23. Serum free carnitine level

    Measured: after 48h of renal replacement therapy

  24. Serum free carnitine level

    Measured: day 7

  25. Serum free carnitine level

    Measured: day 14

  26. Serum free carnitine level

    Measured: month 1

  27. Serum free carnitine level

    Measured: month 2

  28. Serum total carnitine level

    Measured: baseline

  29. Serum total carnitine level

    Measured: after 48h of renal replacement therapy

  30. Serum total carnitine level

    Measured: day 7

  31. Serum total carnitine level

    Measured: day 14

  32. Serum total carnitine level

    Measured: month 1

  33. Serum total carnitine level

    Measured: month 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2016 (estimated)
  2. Study start5 Mar 2018
  3. Primary completion4 Dec 2024
  4. Study completion4 Dec 2024

Why it stopped: Exposure to serious adverse events related to the research (i.e., death), the mnts = 54% versus 58 deaths out of 121 patients = 48%).onitoring committee unanimously recommended discontinuation of the trial.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02664753
Sponsor's protocol ID
PHRC-N/2015/PR-01
Acronym
CarniSave
Status last verified
Aug 2025
First submitted
19 Jan 2016
Last updated
26 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.

    PubMed 12682500

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 56 days of weight-adjusted L-Carnitine treatment in people with Severe Sepsis and Shock, Septic, run by Centre Hospitalier Universitaire de Nīmes at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Exposure to serious adverse events related to the research (i.e., death), the mnts = 54% versus 58 deaths out of 121 patients = 48%).onitoring committee unanimously recommended discontinuation of the trial.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02664753, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.

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