Effect of Rosiglitazone on ADMA in Critical Illness - Full Text View

Sponsored by:	VU University Medical Center
Information provided by:	VU University Medical Center
ClinicalTrials.gov Identifier:	NCT00409097

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Resource links provided by NLM:

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers:	HK0506
Study First Received:	December 7, 2006
Last Updated:	December 7, 2006
ClinicalTrials.gov Identifier:	NCT00409097 History of Changes
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by VU University Medical Center:

ADMA
MOF
Critical illness

Study placed in the following topic categories:

Hypoglycemic Agents
Shock
Critical Illness
Multiple Organ Failure
Rosiglitazone

Additional relevant MeSH terms:

Disease Attributes
Hypoglycemic Agents
Pathologic Processes
Shock
Critical Illness

Multiple Organ Failure
Physiological Effects of Drugs
Rosiglitazone
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2009