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Influence of Corticoids on Renal Function in Cardiac Surgery

This study is not yet open for participant recruitment.
Verified January 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00879931
First received: April 10, 2009
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Elective Cardiac Surgery
 Drug: Methylprednisolone
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Corticoids on Renal Function in Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

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

Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
methylprednisolone
 Drug: Methylprednisolone
Methylprednisolone
Placebo Comparator: 2
Placebo (NaCl 0.9%)
 Drug: Placebo
Placebo (NaCl 0.9%)

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879931

Contacts
Contact: Stefaan Bouchez, MD stefaan.bouchez@ugent.be

Locations
Belgium
University Hospital Ghent Not yet recruiting
Ghent, Belgium, 9000
Contact: Stefaan Bouchez, MD         stefaan.bouchez@ugent.be    
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Stefaan Bouchez, MD University Hospital, Ghent
  More Information

Additional Information:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00879931     History of Changes
Other Study ID Numbers: 2006/031
Study First Received: April 10, 2009
Last Updated: January 29, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Additional relevant MeSH terms:
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 18, 2013