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Completed

NCT Number: NCT00592488

Acetyl-L-Carnitine in the Treatment of Septic Shock

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

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • documented or presumed infection
  • shock requiring vasopressors

Exclusion criteria

  • dialysis
  • hepatic failure
  • seizures

Treatment and study plan

Acetyl-L-carnitine

Drug

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

Other names: ALC

Primary outcomes

  1. Mean Arterial Blood Pressure

    Time frame: 18 hours

    Mean Arterial blood pressure measured non-invasively at 18 hours

Secondary outcomes

  1. Vasopressor Dose

    Time frame: 6-24 hours

    Change in vasopressor dose between 6 and 24 hours.

  2. Serum Lactate

    Time frame: 12-36 hours

    Latest serum lactate between 12 and 36 hours

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Acronym: ALC

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 14, 2008
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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