COBAMAMIDE, LEVOCARNITINE for Septic shock | Acute kidney injury

Inclusion criteria

• {"criterion_text":"- •\tThe 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\n- •\tThe patient must be insured or beneficiary of a health insurance plan\n- •\tThe patient is at least 18 years old\n- •\tThe 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\n- 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)\n- •\tThe patient has acute renal insufficiency with an KDIGO score of 3\n- •\tThe patient has started continuous renal replacement therapy (CRRT) or intermittent renal replacement therapy (IRRT) within the past 72 hours, or will start RRT (CRRT or IRRT) within the next 72 hours."}

Exclusion criteria

• {"criterion_text":"- •\tThe 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\n- •\tThe patient is in an exclusion period determined by a previous study\n- •\tThe patient is under judicial protection, or is an adult under guardianship\n- •\tThe patient is pregnant, parturient or breastfeeding\n- •\tThe 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)\n- •\tIf the patient is unable to sign a consent form: the patient-designated trusted person or family member refuses to sign the consent form\n- •\tIf the patient is unable to sign a consent form: It is impossible to correctly inform the patient-designated trusted person or family member\n- •\tThe patient is able/apt to sign a consent form, but refuses to do so\n- •\tThe patient is able/apt to sign a consent form, but cannot be correctly informed\n- •\tSeptic shock without associated AKI\n- •\tPatients with a known allergy to L-Carnitine or other component of levocarnil oral solution or for injection\n- •\tPre-existing chronic disease requiring dialysis\n- •\tThe patient has stage 4 CKD with baseline DFG (CDK) if known <30 ml\n- •\tHistory of seizures or epilepsy\n- •\tChronic bowel disease or history of chronic diarrhoea\n- •\tUnder treatment with sodium valproate"}

Primary endpoints

• {"endpoint_text":"- Mortality","definition_or_measurement_approach":"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."}

Secondary endpoints

• {"endpoint_text":"- Mortality","definition_or_measurement_approach":""}
• {"endpoint_text":"- Survival (verification of vital status and collection of death certificates to determine date of death)","definition_or_measurement_approach":"Verification of vital status and collection of death certificates to determine date of death."}
• {"endpoint_text":"- Days alive and not on renal replacement therapy","definition_or_measurement_approach":"Count of days the participant is alive and not receiving renal replacement therapy."}
• {"endpoint_text":"- Days alive and free of renal failure","definition_or_measurement_approach":"Count of days the participant is alive and without renal failure."}
• {"endpoint_text":"- Days alive and free of organ failure","definition_or_measurement_approach":"Count of days the participant is alive and free of organ failure."}
• {"endpoint_text":"- Days alive and not on mechanical ventilation","definition_or_measurement_approach":"Count of days the participant is alive and not receiving mechanical ventilation."}
• {"endpoint_text":"- Days alive and not in ICU","definition_or_measurement_approach":"Count of days the participant is alive and not admitted to intensive care unit."}
• {"endpoint_text":"- Days alive and not in hospital","definition_or_measurement_approach":"Count of days the participant is alive and not admitted to hospital."}
• {"endpoint_text":"- Days alive and free of catecholamines","definition_or_measurement_approach":"Count of days the participant is alive and not receiving catecholamine support."}

France

Earliest CTIS Part Ii Submission Date

03-04-2024

Latest Decision Or Authorization Date

21-11-2024

Processing Time Days

232

Number Of Sites

1

Number Of Participants

272

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nimes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France