Effect of Rosiglitazone on ADMA in Critical Illness

Critical Illness Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00409097
• Other study ID #: HK0506
• Status: Recruiting
• Phase: Phase 3
• First received: December 7, 2006
• Last updated: December 7, 2006
• Start date: April 2006
• Est. completion date: December 2007

Study information

• Verified date: December 2006
• Source: VU University Medical Center
• Contact: Milan C Richir, MD
• Phone: 0031 20 4443601
• Email: m.richir[@]vumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Multiple Organ Failure

Intervention

Drug:
• Rosiglitazone

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADMA concentration
Secondary	SOFA score
Secondary	Organ function
Secondary	Mortality