Influence of Corticoids on Renal Function in Cardiac Surgery

This study is not yet open for participant recruitment.

Verified July 2012 by University Hospital, Ghent

Sponsor:

Information provided by (Responsible Party):

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT00879931

First received: April 10, 2009

Last updated: July 17, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 10, 2009

Last Updated Date

July 17, 2012

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Renal dysfunction and renal failure postoperatively in cardiac surgery [ Time Frame: within 48 hours after cardiac surgery ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00879931 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Influence of Corticoids on Renal Function in Cardiac Surgery

Official Title ^ICMJE

Influence of Corticoids on Renal Function in Cardiac Surgery

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%.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Elective Cardiac Surgery

Intervention ^ICMJE

Drug: Methylprednisolone
Methylprednisolone
Drug: Placebo
Placebo (NaCl 0.9%)

Study Arm (s)

Experimental: 1
methylprednisolone

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

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Stefaan Bouchez, MD

stefaan.bouchez@ugent.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00879931

Other Study ID Numbers ^ICMJE

2006/031

Has Data Monitoring Committee

Responsible Party

University Hospital, Ghent

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Stefaan Bouchez, MD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

July 2012

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

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