L-Carnitine Administration in Early Sepsis

What Was Tested

The trial (phase 1) is built around L-Carnitine.

Sepsis is a severe and overwhelming response to an infection in the body.

Over 750,000 patients in the United States develop sepsis every year.

As sepsis becomes progressively more severe, a patient's blood pressure drops to dangerous levels and the body cannot pump oxygen to the rest of the body, which is necessary for normal cell function.

It had two arms (groups): Saline (placebo comparator) and L-Carnitine (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 31 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: Suspected or confirmed infection. Any two of four criteria of systemic inflammatory response. Requirement for vasopressors to treat shock. Enrollment within 12 hours of vasopressor initiation. SOFA score of greater than or equal to 5 at the time of enrollment.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: age \<18 years; pregnancy or breastfeeding; any primary diagnosis other than sepsis.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2010-09 with completion listed for 2012-02.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Microcirculation, ICU and hospital length of stay, All-cause mortality, All-cause mortality, All-cause mortality and All-cause mortality.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of L-Carnitine in 31 people.

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

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.