Effect of Rosiglitazone on ADMA in Critical Illness

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. Identifier: NCT00409097
Recruitment Status : Unknown
Verified December 2006 by VU University Medical Center.
Recruitment status was:  Recruiting
First Posted : December 8, 2006
Last Update Posted : December 8, 2006
Information provided by:
VU University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Critical Illness Multiple Organ Failure Drug: Rosiglitazone Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2006
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. ADMA concentration

Secondary Outcome Measures :
  1. SOFA score
  2. Organ function
  3. Mortality

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

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

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 identifier (NCT number): NCT00409097

Contact: Milan C Richir, MD 0031 20 4443601

VU University Medical Center Recruiting
Amsterdam, Netherlands, 1081 HV
Contact: Milan C Richir, MD    0031 20 4443601   
Principal Investigator: Milan C Richir, MD         
Sponsors and Collaborators
VU University Medical Center
Study Director: Paul am Leeuwen van, MD, PhD VU University Medical Center Identifier: NCT00409097     History of Changes
Other Study ID Numbers: HK0506
First Posted: December 8, 2006    Key Record Dates
Last Update Posted: December 8, 2006
Last Verified: December 2006

Keywords provided by VU University Medical Center:
Critical illness

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