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

What Was Tested

This registered phase 3 trial tested L-Carnitine.

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.

It had two arms (groups): L-Carnitine group (experimental) and Placebo then open group (placebo comparator).

Patients in the experimental arm will receive 10 days of intravenous L-carnitine treatment followed by 46 days of oral L-Carnitine treatment. Intervention: 56 days of weight-adjusted L-Carnitine treatment.

Patients in the placebo arm will receive 10 days of intravenous isotonic saline in a fashion analogous to the experimental arm (they study is thus blinded for the first 10 days and then open there afterwards). Intervention: 10 days of intravenous placebo (isotonic saline).

The registry classes the interventions as drug.

More on the Plan

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.

To compare study arms in terms of further clinical outcomes, with special emphasis on nephrological outcomes.

Who Took Part

The registry lists 254 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: The patient is at least 18 years old. The patient has acute renal insufficiency with an KDIGO score of 3.

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: the patient is in an exclusion period determined by a previous study; the patient is under judicial protection, or is an adult under guardianship; the patient is pregnant, parturient or breastfeeding.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2018-03-05 with completion listed for 2024-12-04.

It ran at 11 sites in France (11).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mortality (time frame: 28 days).

It also tracked 33 secondary outcomes, for example Adverse Events per patient, Survival, The number of days alive and not on renal replacement therapy, The number of days alive and free of renal failure, The number of days alive and free of organ failure and The number of days alive and not on mechanical ventilation.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 254 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.