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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00879931
Other study ID # 2006/031
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2013
Est. completion date July 2015

Study information

Verified date December 2022
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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%.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 - patiƫnts with renal dysfunction: creatinine > 2mg/dl - patiƫnts treated with corticoids

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Methylprednisolone
Methylprednisolone
Placebo
Placebo (NaCl 0.9%)

Locations

Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Renal dysfunction and renal failure postoperatively in cardiac surgery within 48 hours after cardiac surgery
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