NCT00592488

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 8, 2011

Completed
Last Updated

December 8, 2017

Status Verified

November 1, 2017

Enrollment Period

3 years

First QC Date

January 2, 2008

Results QC Date

March 17, 2011

Last Update Submit

November 7, 2017

Conditions

Septic Shock

Keywords

Septic shockAcetyl-L-carnitine

Outcome Measures

Primary Outcomes (1)

  • Mean Arterial Blood Pressure

    Mean Arterial blood pressure measured non-invasively at 18 hours

    18 hours

Secondary Outcomes (2)

  • Vasopressor Dose

    6-24 hours

  • Serum Lactate

    12-36 hours

Study Arms (2)

A

OTHER

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

Drug: Acetyl-L-Carnitine

B

OTHER

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

Drug: Acetyl-L-Carnitine

Interventions

Acetyl-L-CarnitineDRUG

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

Also known as: ALC
AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • documented or presumed infection
  • shock requiring vasopressors

You may not qualify if:

  • dialysis
  • hepatic failure
  • seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Acetylcarnitine

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

CarnitineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Results Point of Contact

Title
Todd Rice, MD
Organization
Vanderbilt University
todd.rice@vanderbilt.edu
615 322-3412

Study Officials

  • Todd W. Rice, MD, MSc

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 14, 2008

Study Start

August 1, 2006

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

December 8, 2017

Results First Posted

June 8, 2011

Record last verified: 2017-11

Locations

US(1)