Influence of Corticoids on Renal Function in Cardiac Surgery

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. Identifier: NCT00879931
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : April 13, 2009
Last Update Posted : December 5, 2014
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:

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 or disease Intervention/treatment Phase
Elective Cardiac Surgery Drug: Methylprednisolone Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Corticoids on Renal Function in Cardiac Surgery
Study Start Date : January 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: Methylprednisolone

Placebo Comparator: 2
Placebo (NaCl 0.9%)
Drug: Placebo
Placebo (NaCl 0.9%)

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00879931

Contact: Stefaan Bouchez, MD

University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Stefaan Bouchez, MD   
Sponsors and Collaborators
University Hospital, Ghent
Principal Investigator: Stefaan Bouchez, MD University Hospital, Ghent

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

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