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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Criteria

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 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 has been admitted to a participating ICU for severe sepsis or septic shock within the last 72 hours

• 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 past 24 hours, or will start RRT (CRRT or IRRT) within the next 24 hours

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 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

• If the patient is unable to sign a consent form: the patient-designated trusted person or family member refuses to sign the consent form

• 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

• 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