Phase
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
Ages > 18 All Genders
Study Summary
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 familymember, or a medical decision to proceed with patient inclusion if the latter twopersons 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, 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 forSepsis 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) 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 threemonths, another interventional study that may interfere with the results orconclusions 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 effectivecontraception (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 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 correctlyinformed
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
Study Description
Connect with a study center
CHU d'Angers - Hôtel-Dieu
Angers, 49933
FranceSite Not Available
CHU de Caen
Caen 3029241, 14033
FranceSite Not Available
CHU de Caen
Caen Cedex 9, 14033
FranceSite Not Available
CH de Chartres
Chartres,
FranceSite Not Available
CH de Chartres
Chartres 3026467,
FranceSite Not Available
CHU de Clermont Ferrand
Clermont Ferrand, 63003
FranceSite Not Available
CHU de Clermont Ferrand
Clermont-Ferrand 3024635, 63003
FranceSite Not Available
CHU de Dijon
Dijon, 21079
FranceSite Not Available
CHU de Dijon
Dijon 3021372, 21079
FranceSite Not Available
CHU Lyon
Lyon,
FranceSite Not Available
CHU Lyon
Lyon 2996944,
FranceSite Not Available
APHM - Hôpital de la Conception
Marseille, 13385
FranceSite Not Available
APHM - Hôpital de la Timone Adultes
Marseille, 13385
FranceSite Not Available
APHM - Hôpital Nord
Marseille Cedex 20, 13915
FranceSite Not Available
CHU de Montpellier - Lapeyronie
Montpellier, 34295
FranceSite Not Available
CHU de Montpellier - Lapeyronie
Montpellier 2992166, 34295
FranceSite Not Available
CHU de Montpellier - St Eloi
Montpellier 2992166, 34295
FranceSite Not Available
CHU de Montpellier - St Eloi
Montpellier cedex 5, 34295
FranceSite Not Available
CHU de Nice - Hôpital Pasteur 2
Nice, 06002
FranceSite Not Available
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes 2990363, 30029
FranceSite Not Available
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, 30029
FranceSite Not Available
CHU de Poitiers
Poitiers 2986495, 86021
FranceSite Not Available
CHU de Poitiers
Poitiers Cedex, 86021
FranceSite Not Available
CHU de St Etienne
Saint-Priest en Jarez, 42270
FranceSite Not Available
CHU de St Etienne
Saint-Priest-en-Jarez 2977350, 42270
FranceSite Not Available
CHU de Toulouse - Hôpital Rangueil
Toulouse 2972315, 31059 T
FranceSite Not Available
CHU de Toulouse - Hôpital Rangueil
Toulouse Cedex 9, 31059 T
FranceSite Not Available
CHU de Toulouse - Hôpital Rangueil
oulouse Cedex 9, 31059 T
FranceSite Not Available

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