search
Back to results

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

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acetyl-L-Carnitine
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Septic shock, Acetyl-L-carnitine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • documented or presumed infection
  • shock requiring vasopressors

Exclusion Criteria:

  • dialysis
  • hepatic failure
  • seizures

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 2, 2008
Last Updated
November 7, 2017
Sponsor
Vanderbilt University
search

1. Study Identification

Unique Protocol Identification Number
NCT00592488
Brief Title
Acetyl-L-Carnitine in the Treatment of Septic Shock
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Septic shock, Acetyl-L-carnitine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours
Arm Title
B
Arm Type
Other
Arm Description
Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours
Intervention Type
Drug
Intervention Name(s)
Acetyl-L-Carnitine
Other Intervention Name(s)
ALC
Intervention Description
Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours
Primary Outcome Measure Information:
Title
Mean Arterial Blood Pressure
Description
Mean Arterial blood pressure measured non-invasively at 18 hours
Time Frame
18 hours
Secondary Outcome Measure Information:
Title
Vasopressor Dose
Description
Change in vasopressor dose between 6 and 24 hours.
Time Frame
6-24 hours
Title
Serum Lactate
Description
Latest serum lactate between 12 and 36 hours
Time Frame
12-36 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: documented or presumed infection shock requiring vasopressors Exclusion Criteria: dialysis hepatic failure seizures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd W. Rice, MD, MSc
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Acetyl-L-Carnitine in the Treatment of Septic Shock

We'll reach out to this number within 24 hrs