NCT00409097

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 8, 2006

Status Verified

December 1, 2006

First QC Date

December 7, 2006

Last Update Submit

December 7, 2006

Conditions

Critical IllnessMultiple Organ Failure

Keywords

ADMAMOFCritical illness

Outcome Measures

Primary Outcomes (1)

  • ADMA concentration

Secondary Outcomes (3)

  • SOFA score

  • Organ function

  • Mortality

Interventions

RosiglitazoneDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • critically ill patients
  • age between 18 and 75 years
  • SOFA score \> 7

You may not qualify if:

  • history of Diabetes mellitus
  • history of hypercholesterolemia
  • history of hyperhomocysteinemia
  • impaired hepatic function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU University Medical Center

Amsterdam, 1081 HV, Netherlands

RECRUITING

MeSH Terms

Conditions

Critical IllnessMultiple Organ Failure

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Paul am Leeuwen van, MD, PhD

    Amsterdam UMC, location VUmc

    STUDY DIRECTOR

Central Study Contacts

Milan C Richir, MD

CONTACT

0031 20 4443601m.richir@vumc.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 8, 2006

Study Start

April 1, 2006

Study Completion

December 1, 2007

Last Updated

December 8, 2006

Record last verified: 2006-12

Locations

NL(1)