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 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
Study Description
Connect with a study center
CHU d'Angers - Hôtel-Dieu
Angers, 49933
FranceSite Not Available
CHU de Caen
Caen Cedex 9, 14033
FranceActive - Recruiting
CH de Chartres
Chartres,
FranceActive - Recruiting
CHU de Clermont Ferrand
Clermont Ferrand, 63003
FranceActive - Recruiting
CHU de Dijon
Dijon, 21079
FranceActive - Recruiting
CHU Lyon
Lyon,
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
FranceActive - Recruiting
CHU de Montpellier - St Eloi
Montpellier cedex 5, 34295
FranceActive - Recruiting
CHU de Nice - Hôpital Pasteur 2
Nice, 06002
FranceSite Not Available
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, 30029
FranceActive - Recruiting
CHU de Poitiers
Poitiers Cedex, 86021
FranceActive - Recruiting
CHU de St Etienne
Saint-Priest en Jarez, 42270
FranceSite Not Available
CHU de Toulouse - Hôpital Rangueil
Toulouse Cedex 9, 31059 T
FranceActive - Recruiting
CHU de Toulouse - Hôpital Rangueil
oulouse Cedex 9, 31059 T
FranceSite Not Available
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