Acetyl-L-Carnitine in the Treatment of Septic Shock

Phase 1

Completed

• Conditions: Septic Shock
• Interventions: Drug: Acetyl-L-Carnitine

• Registration Number: NCT00592488
• Lead Sponsor: Vanderbilt University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2008-01-02
• Study First Submitted QC: 2008-01-11
• Study First Posted: 2008-01-14
• Primary Completion: 2009-08
• Study Completion: 2009-09
• Results First Submitted: 2011-03-17
• Results First Submitted QC: 2011-05-09
• Results First Posted: 2011-06-08
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• documented or presumed infection
• shock requiring vasopressors

Exclusion Criteria

• dialysis
• hepatic failure
• seizures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Acetyl-L-Carnitine	Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours
B	Acetyl-L-Carnitine	Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours

Primary Outcome Measures

Name	Time	Method
Mean Arterial Blood Pressure	18 hours	Mean Arterial blood pressure measured non-invasively at 18 hours

Secondary Outcome Measures

Name	Time	Method
Vasopressor Dose	6-24 hours	Change in vasopressor dose between 6 and 24 hours.
Serum Lactate	12-36 hours	Latest serum lactate between 12 and 36 hours

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States