Acetyl-L-Carnitine in the Treatment of Septic Shock

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test L-Carnitine.

This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic shock requiring vasopressors.

It had two arms (groups): A (other) and B (other).

Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours.

Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours.

The registry classes the interventions as drug.

More on the Plan

This is a cross-over study which infuses ALC for 12 out of 18 hours (and placebo the other 6).

Patients must have vasopressor-dependent septic shock and be free from renal failure, hepatic failure, and seizures to be eligible.

Who Took Part

Enrollment: 13 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: Documented or presumed infection. Shock requiring vasopressors.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: hepatic failure.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

In the crossover set-up each of the participants took both L-Carnitine and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2006-08 with completion listed for 2009-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean Arterial Blood Pressure (time frame: 18 hours).

It also tracked 2 secondary outcomes, for example Serum Lactate.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of L-Carnitine in 13 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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