The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Maastricht University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00821158
First received: January 12, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Ischemia-Reperfusion
Drug: Antioxidant
Other: Placebo
Drug: Anti-inflammatory drug
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Antioxidant concentrations [ Time Frame: 0,5-24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2009
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo tablet and iv
Other: Placebo
Placebo tablet and iv
Experimental: 2
Placebo tablet and intervention iv
Drug: Antioxidant
Antioxidant iv bolus
Experimental: 3
Intervention tablet and placebo iv
Drug: Anti-inflammatory drug
Anti-inflammatory tablet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing breast reconstruction

Exclusion Criteria:

  • Diabetes mellitus
  • Kidney or liver disease
  • Use of immunosuppressants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821158

Contacts
Contact: Marieke van den Heuvel, M.D. 0031-43-3875496 m.vandenheuvel@ah.unimaas.nl
Contact: R. van der Hulst, M.D., Phd 0031-43-3877481 r.vander.hulst@mumc.nl

Locations
Netherlands
Maastricht University Medical Center Not yet recruiting
Maastricht, Netherlands, P.O. Box 5800, 6202 AZ
Contact: Marieke van den Heuvel, M.D.    0031-43-3875496    m.vandenheuvel@ah.unimaas.nl   
Principal Investigator: Marieke van den Heuvel, M.D.         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Chair: R. van der Hulst, M.D., Phd Maastricht Universtity Medical Center
Principal Investigator: Marieke van den Heuvel, M.D. Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: R. van der Hulst, M.D., Phd, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00821158     History of Changes
Other Study ID Numbers: MEC 25-11-2008
Study First Received: January 12, 2009
Last Updated: January 12, 2009
Health Authority: Netherlands: Independent Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Ischemia
Pathologic Processes
Anti-Inflammatory Agents
Antioxidants
Therapeutic Uses
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014