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

Last updated: May 7, 2024
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Recruiting

Phase

3

Condition

Soft Tissue Infections

Low Blood Pressure (Hypotension)

Kidney Failure

Treatment

56 days of weight-adjusted L-Carnitine treatment

10 days of intravenous placebo (isotonic saline)

Clinical Study ID

NCT02664753
PHRC-N/2015/PR-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 areunavailable) ---- 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, atsome point, the use of extra-renal purification.
  • • The patient has sepsis or septic shock according to international criteriaSEPSIS 3 (Singer et al, The Third International Consensus Definitions for Sepsisand 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) orintermittent renal replacement therapy (IRRT) within the previous 72 hours, orwill start RRT (CRRT or IRRT) within the next 72 hours.

Exclusion

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 ofthis 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 effectivecontraception (contraceptive hormonal ring, surgical contraception, contraceptiveimplant, contraceptive pill, male or female sheaths, skin patch, intrauterinecontraceptive device)
  • If the patient is unable to sign a consent form: the patient-designated trustedperson or family member refuses to sign the consent form
  • If the patient is unable to sign a consent form: It is impossible to correctlyinform 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 levocarniloral 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

Study Design

Total Participants: 272
Treatment Group(s): 2
Primary Treatment: 56 days of weight-adjusted L-Carnitine treatment
Phase: 3
Study Start date:
March 05, 2018
Estimated Completion Date:
May 31, 2026

Study Description

The secondary objectives of this study are:

A. 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

B. To compare study arms in terms of patient safety.

C. To compare study arms in terms of further clinical outcomes, with special emphasis on nephrological outcomes.

D. 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.

E. 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.

Connect with a study center

  • CHU d'Angers - Hôtel-Dieu

    Angers, 49933
    France

    Site Not Available

  • CHU de Caen

    Caen Cedex 9, 14033
    France

    Active - Recruiting

  • CH de Chartres

    Chartres,
    France

    Active - Recruiting

  • CHU de Clermont Ferrand

    Clermont Ferrand, 63003
    France

    Active - Recruiting

  • CHU de Dijon

    Dijon, 21079
    France

    Active - Recruiting

  • CHU Lyon

    Lyon,
    France

    Site Not Available

  • APHM - Hôpital de la Conception

    Marseille, 13385
    France

    Site Not Available

  • APHM - Hôpital de la Timone Adultes

    Marseille, 13385
    France

    Site Not Available

  • APHM - Hôpital Nord

    Marseille Cedex 20, 13915
    France

    Site Not Available

  • CHU de Montpellier - Lapeyronie

    Montpellier, 34295
    France

    Active - Recruiting

  • CHU de Montpellier - St Eloi

    Montpellier cedex 5, 34295
    France

    Active - Recruiting

  • CHU de Nice - Hôpital Pasteur 2

    Nice, 06002
    France

    Site Not Available

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes Cedex 09, 30029
    France

    Active - Recruiting

  • CHU de Poitiers

    Poitiers Cedex, 86021
    France

    Active - Recruiting

  • CHU de St Etienne

    Saint-Priest en Jarez, 42270
    France

    Site Not Available

  • CHU de Toulouse - Hôpital Rangueil

    Toulouse Cedex 9, 31059 T
    France

    Active - Recruiting

  • CHU de Toulouse - Hôpital Rangueil

    oulouse Cedex 9, 31059 T
    France

    Site Not Available

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