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NCT00592488 Clinical Trial

Acetyl-L-Carnitine in the Treatment of Septic Shock

Septic Shock Clinical Trial

— ALC  

Official title:
Prospective, Randomized, Placebo-controlled, Double-Blinded, Phase II Pilot Study of Acetyl-L-carnitine in the Treatment of Patients With Septic Shock

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00592488
Other study ID # 050730
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received January 2, 2008
Last updated November 7, 2017
Start date August 2006
Est. completion date September 2009

Study information
Verified date November 2017
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date September 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- documented or presumed infection

- shock requiring vasopressors

Exclusion Criteria:

- dialysis

- hepatic failure

- seizures

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Acetyl-L-Carnitine
Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Arterial Blood Pressure Mean Arterial blood pressure measured non-invasively at 18 hours 18 hours
Secondary Vasopressor Dose Change in vasopressor dose between 6 and 24 hours. 6-24 hours
Secondary Serum Lactate Latest serum lactate between 12 and 36 hours 12-36 hours
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