Influence of Corticoids on Renal Function in Cardiac Surgery

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00879931
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 29.9
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Jan 1, 2013
• Anticipated Primary Completion Date: Jul 1, 2015
• Anticipated Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 methylprednisolone	Drug: Methylprednisolone; Methylprednisolone
Placebo Comparator: 2 Placebo (NaCl 0.9%)	Drug: Placebo; Placebo (NaCl 0.9%)

Outcome Measures

Primary Outcome Measures

1. Renal dysfunction and renal failure postoperatively in cardiac surgery [within 48 hours after cardiac surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Stefaan Bouchez, MD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website of the University Hospital Ghent

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT00879931
• Other Study ID Numbers: 2006/031
• First Posted: Apr 13, 2009
• Last Update Posted: Dec 5, 2014
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

No Results Posted as of Dec 5, 2014