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Influence of Corticoids on Renal Function in Cardiac Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00879931
First Posted: April 13, 2009
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose

Hypothesis: Corticoid treatment in cardiac surgery works renal protective.

Study design: Randomized, double blind trial in which one group of patients will receive methylprednisolone and the other group (control) will receive placebo NaCl 0.9%.


Condition Intervention Phase
Elective Cardiac Surgery Drug: Methylprednisolone Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Corticoids on Renal Function in Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Renal dysfunction and renal failure postoperatively in cardiac surgery [ Time Frame: within 48 hours after cardiac surgery ]

Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
methylprednisolone
Drug: Methylprednisolone
Methylprednisolone
Placebo Comparator: 2
Placebo (NaCl 0.9%)
Drug: Placebo
Placebo (NaCl 0.9%)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 20-80 year
  • patients scheduled for elective cardiac surgery.
  • preoperative creatinine levels of < 2mg/dl
  • no corticoid treatment

Exclusion Criteria:

  • non-elective surgery
  • patiënts with renal dysfunction: creatinine > 2mg/dl
  • patiënts treated with corticoids
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879931


Contacts
Contact: Stefaan Bouchez, MD stefaan.bouchez@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Stefaan Bouchez, MD       stefaan.bouchez@ugent.be   
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Stefaan Bouchez, MD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00879931     History of Changes
Other Study ID Numbers: 2006/031
First Submitted: April 10, 2009
First Posted: April 13, 2009
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents