Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Influence of Corticoids on Renal Function in Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00879931
First received: April 10, 2009
Last updated: December 4, 2014
Last verified: December 2014

April 10, 2009
December 4, 2014
January 2013
July 2015   (final data collection date for primary outcome measure)
Renal dysfunction and renal failure postoperatively in cardiac surgery [ Time Frame: within 48 hours after cardiac surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00879931 on ClinicalTrials.gov Archive Site
Not Provided
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Influence of Corticoids on Renal Function in Cardiac Surgery
Influence of Corticoids on Renal Function in Cardiac Surgery

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%.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Elective Cardiac Surgery
  • Drug: Methylprednisolone
    Methylprednisolone
  • Drug: Placebo
    Placebo (NaCl 0.9%)
  • Experimental: 1
    methylprednisolone
    Intervention: Drug: Methylprednisolone
  • Placebo Comparator: 2
    Placebo (NaCl 0.9%)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years   (Adult, Senior)
No
Contact: Stefaan Bouchez, MD stefaan.bouchez@ugent.be
Belgium
 
NCT00879931
2006/031
No
Not Provided
Not Provided
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Stefaan Bouchez, MD University Hospital, Ghent
University Hospital, Ghent
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP