MedDataX Logo

Acetyl-L-Carnitine in the Treatment of Septic Shock

NCT ID: NCT00592488

Last Updated: 2017-12-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Septic Shock

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Septic shock Acetyl-L-carnitine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

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

Group Type OTHER

Acetyl-L-Carnitine

Intervention Type DRUG

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

B

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

Group Type OTHER

Acetyl-L-Carnitine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acetyl-L-Carnitine

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ALC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* documented or presumed infection
* shock requiring vasopressors

Exclusion Criteria

* dialysis
* hepatic failure
* seizures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Todd Rice

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Todd W. Rice, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

050730

Identifier Type: -

Identifier Source: org_study_id