Influence of Corticoids on Renal Function in Cardiac Surgery

NCT ID: NCT00879931

Last Updated: 2022-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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Elective Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

methylprednisolone

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type DRUG

Methylprednisolone

2

Placebo (NaCl 0.9%)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (NaCl 0.9%)

Interventions

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Methylprednisolone

Methylprednisolone

Intervention Type DRUG

Placebo

Placebo (NaCl 0.9%)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefaan Bouchez, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2006/031

Identifier Type: -

Identifier Source: org_study_id

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