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

Acute Kidney Injury Clinical Trial

Official title: L-carnitine as an Adjunct Treatment for Septic Shock Patients With Acute Kidney Injury: a Multicentre, Randomized, 2-parallel Group, Superiority Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Acute Kidney Injury
• Sepsis
• Severe Sepsis
• Shock
• Shock, Septic
• Wounds and Injuries

• NCT number: NCT02664753
• Study type: Interventional
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Pascal Reboul, MD
• Phone: +33.(0)4.66.68.35.56
• Email: pascal.reboul@chu-nimes.fr
• Status: Recruiting
• Phase: Phase 3
• Start date: March 5, 2018
• Completion date: May 2026