Effect of Rosiglitazone on ADMA in Critical Illness

• Sponsor: Amsterdam UMC, location VUmc (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00409097
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 20
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2006
• Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

1. ADMA concentration []

Secondary Outcome Measures

1. SOFA score []

2. Organ function []

3. Mortality []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VU University Medical Center	Amsterdam		Netherlands	1081 HV

Sponsors and Collaborators

• Amsterdam UMC, location VUmc

Investigators

• Study Director: Paul am Leeuwen van, MD, PhD, Amsterdam UMC, location VUmc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00409097
• Other Study ID Numbers: HK0506
• First Posted: Dec 8, 2006
• Last Update Posted: Dec 8, 2006
• Last Verified: Dec 1, 2006

• Keywords provided by , ,: ADMA; MOF; Critical illness
• Additional relevant MeSH terms: Critical Illness; Multiple Organ Failure; Rosiglitazone

Study Results

No Results Posted as of Dec 8, 2006