Acetyl-L-Carnitine in the Treatment of Septic Shock (ALC)

Vanderbilt University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Septic Shock

Treatments: Drug: Acetyl-L-Carnitine

Study type: Interventional

Funder types: Other

Identifiers

NCT00592488

050730

Details and patient eligibility

About

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

Full description

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• documented or presumed infection
• shock requiring vasopressors

Exclusion criteria

• dialysis
• hepatic failure
• seizures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups

A

Other group

Description:

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

Treatment:

Drug: Acetyl-L-Carnitine

B

Other group

Description:

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

Treatment:

Drug: Acetyl-L-Carnitine