Effect of Rosiglitazone on ADMA in Critical Illness

December 7, 2006 updated by: Amsterdam UMC, location VUmc
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Recruiting
        • VU University Medical Center
        • Contact:
        • Principal Investigator:
          • Milan C Richir, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
ADMA concentration

Secondary Outcome Measures

Outcome Measure
Mortality
SOFA score
Organ function

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

December 7, 2006

First Submitted That Met QC Criteria

December 7, 2006

First Posted (Estimate)

December 8, 2006

Study Record Updates

Last Update Posted (Estimate)

December 8, 2006

Last Update Submitted That Met QC Criteria

December 7, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HK0506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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