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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00821158
Other study ID # MEC 25-11-2008
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received January 12, 2009
Last updated January 12, 2009
Start date February 2009

Study information

Verified date January 2009
Source Maastricht University Medical Center
Contact Marieke van den Heuvel, M.D.
Phone 0031-43-3875496
Email m.vandenheuvel@ah.unimaas.nl
Is FDA regulated No
Health authority Netherlands: Independent Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing breast reconstruction

Exclusion Criteria:

- Diabetes mellitus

- Kidney or liver disease

- Use of immunosuppressants

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Antioxidant
Antioxidant iv bolus
Other:
Placebo
Placebo tablet and iv
Drug:
Anti-inflammatory drug
Anti-inflammatory tablet

Locations

Country Name City State
Netherlands Maastricht University Medical Center Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antioxidant concentrations 0,5-24 hours No
See also
  Status Clinical Trial Phase
Terminated NCT02254642 - Effects of Ischemic Preconditioning After Aortic Clamping N/A
Completed NCT00482469 - The DIEP-Flap as a Model of Ischemia-Reperfusion N/A