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Effect of Rosiglitazone on ADMA in Critical Illness

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by VU University Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00409097
First Posted: December 8, 2006
Last Update Posted: December 8, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VU University Medical Center
  Purpose
The purpose of this study is to determine whether Rosiglitazone,decreases the ADMA concentration and thereby increases the arginine/ADMA ratio of critically ill patients.

Condition Intervention Phase
Critical Illness Multiple Organ Failure Drug: Rosiglitazone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • ADMA concentration

Secondary Outcome Measures:
  • SOFA score
  • Organ function
  • Mortality

Estimated Enrollment: 30
Study Start Date: April 2006
Estimated Study Completion Date: December 2007
Detailed Description:
Endothelial vasodilatation dysfunction precedes the development of arteriosclerosis. The endothelium plays a pivotal role in the control of the vascular tone by releasing nitric oxide (NO). The amino acid arginine is the sole substrate for the enzyme NO synthase (NOS). Asymmetric dimethylarginine (ADMA) is an endogenous derivative of arginine that inhibits NOS. Thus the arginine/ADMA ratio an important determinant of NO production by NOS. ADMA is an independent risk factor for cardiovascular disease, but elevated levels of ADMA have also been shown to be a strong independent predictor of ICU mortality. The central mechanism by which ADMA may cause deterioration in critically ill patients is by impairing organ blood flow and reducing cardiac function, especially during stress. Accumulation of ADMA could thereby be a causative factor in the development multi organ failure (MOF). Thus inhibition of NO production by ADMA may become especially important when cardiac demand is increased.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • critically ill patients
  • age between 18 and 75 years
  • SOFA score > 7

Exclusion Criteria:

  • history of Diabetes mellitus
  • history of hypercholesterolemia
  • history of hyperhomocysteinemia
  • impaired hepatic function
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409097


Contacts
Contact: Milan C Richir, MD 0031 20 4443601 m.richir@vumc.nl

Locations
Netherlands
VU University Medical Center Recruiting
Amsterdam, Netherlands, 1081 HV
Contact: Milan C Richir, MD    0031 20 4443601    m.richir@vumc.nl   
Principal Investigator: Milan C Richir, MD         
Sponsors and Collaborators
VU University Medical Center
Investigators
Study Director: Paul am Leeuwen van, MD, PhD VU University Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00409097     History of Changes
Other Study ID Numbers: HK0506
First Submitted: December 7, 2006
First Posted: December 8, 2006
Last Update Posted: December 8, 2006
Last Verified: December 2006

Keywords provided by VU University Medical Center:
ADMA
MOF
Critical illness

Additional relevant MeSH terms:
Critical Illness
Multiple Organ Failure
Disease Attributes
Pathologic Processes
Shock
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs


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