Influence of Corticoids on Renal Function in Cardiac Surgery | NCT00879931

Studies
Influence of Corticoids on Renal Function in Cardiac Surgery

NCT00879931

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Dec 7, 2022Actual

Enrollment

80Actual

Phase

Phase 2

Conditions

Elective Cardiac Surgery

Interventions

Methylprednisolone
Placebo

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013Actual

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Apr 10, 2009

First Submission Date that Met QC Criteria

Apr 10, 2009

First Posted Date

Apr 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2022

Last Update Posted Date

Dec 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	methylprednisolone	Drug: Methylprednisolone
2	Placebo Comparator	Placebo (NaCl 0.9%)	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methylprednisolone	Drug	Methylprednisolone	1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Renal dysfunction and renal failure postoperatively in cardiac surgery		within 48 hours after cardiac surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefaan Bouchez, MD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

Label	URL
Website of the University Hospital Ghent	View source

Intervention Browse Module

MeSH Terms

ID	Term
D008775	Methylprednisolone

Ancestor Terms

ID	Term
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes

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Browse Branches

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