Influence of Corticoids on Renal Function in Cardiac Surgery

Phase 2

Completed

• Conditions: Elective Cardiac Surgery
• Interventions: Drug: Placebo; Drug: Methylprednisolone

• Registration Number: NCT00879931
• Lead Sponsor: 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%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-10
• Study First Submitted QC: 2009-04-10
• Study First Posted: 2009-04-13
• Study Start: 2013-01
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo (NaCl 0.9%)
1	Methylprednisolone	methylprednisolone

Primary Outcome Measures

Name	Time	Method
Renal dysfunction and renal failure postoperatively in cardiac surgery	within 48 hours after cardiac surgery

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium