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

November 7, 2017 updated by: Todd Rice, Vanderbilt University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • documented or presumed infection
  • shock requiring vasopressors

Exclusion Criteria:

  • dialysis
  • hepatic failure
  • seizures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A
Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours
Drug: Acetyl-L-Carnitine
Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours
Other Names:
  • ALC
Other: B
Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours
Drug: Acetyl-L-Carnitine
Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours
Other Names:
  • ALC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Arterial Blood Pressure
Time Frame: 18 hours
Mean Arterial blood pressure measured non-invasively at 18 hours
18 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vasopressor Dose
Time Frame: 6-24 hours
Change in vasopressor dose between 6 and 24 hours.
6-24 hours
Serum Lactate
Time Frame: 12-36 hours
Latest serum lactate between 12 and 36 hours
12-36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Todd W. Rice, MD, MSc, Vanderbilt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

January 2, 2008

First Submitted That Met QC Criteria

January 11, 2008

First Posted (Estimate)

January 14, 2008

Study Record Updates

Last Update Posted (Actual)

December 8, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 050730

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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