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

  • STATUS
    Recruiting
  • End date
    Apr 16, 2025
  • participants needed
    272
  • sponsor
    Centre Hospitalier Universitaire de Nīmes
Updated on 16 March 2022
severe sepsis
shock
renal replacement therapy
septic shock

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.

Description

The secondary objectives of this study are:

  1. 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
  2. To compare study arms in terms of patient safety.
  3. To compare study arms in terms of further clinical outcomes, with special emphasis on nephrological outcomes.
  4. 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.
  5. 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.

Details
Condition Severe Sepsis, Shock, Septic, Acute Kidney Injury
Treatment 56 days of weight-adjusted L-Carnitine treatment, 10 days of intravenous placebo (isotonic saline)
Clinical Study IdentifierNCT02664753
SponsorCentre Hospitalier Universitaire de Nīmes
Last Modified on16 March 2022

Eligibility

Yes No Not Sure

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
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