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L-carnitine as an Adjunct Treatment for Septic Shock Patients With Acute Kidney Injury: a Multicentre, Randomized, 2-parallel Group, Superiority Trial
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.
The secondary objectives of this study are: A. 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 B. To compare study arms in terms of patient safety. C. To compare study arms in terms of further clinical outcomes, with special emphasis on nephrological outcomes. D. 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. E. 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU de Caen
Caen, France
CH de Chartres
Chartres, France
CHU de Clermont Ferrand
Clermont-Ferrand, France
CHU de Dijon
Dijon, France
CHU Lyon
Lyon, France
CHU de Montpellier - Lapeyronie
Montpellier, France
CHU de Montpellier - St Eloi
Montpellier, France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
CHU de Poitiers
Poitiers, France
CHU de St Etienne
Saint-Priest-en-Jarez, France
Start Date
March 5, 2018
Primary Completion Date
December 4, 2024
Completion Date
December 4, 2024
Last Updated
August 26, 2025
254
ACTUAL participants
56 days of weight-adjusted L-Carnitine treatment
DRUG
10 days of intravenous placebo (isotonic saline)
DRUG
Lead Sponsor
Centre Hospitalier Universitaire de Nīmes
NCT05806645
NCT07472426
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04955210