NCT00879931

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
3.7 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

2.5 years

First QC Date

April 10, 2009

Last Update Submit

December 6, 2022

Conditions

Elective Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • Renal dysfunction and renal failure postoperatively in cardiac surgery

    within 48 hours after cardiac surgery

Study Arms (2)

1

EXPERIMENTAL

methylprednisolone

Drug: Methylprednisolone

2

PLACEBO COMPARATOR

Placebo (NaCl 0.9%)

Drug: Placebo

Interventions

MethylprednisoloneDRUG

Methylprednisolone

1
PlaceboDRUG

Placebo (NaCl 0.9%)

2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 20-80 year
  • patients scheduled for elective cardiac surgery.
  • preoperative creatinine levels of \< 2mg/dl
  • no corticoid treatment

You may not qualify if:

  • non-elective surgery
  • patiënts with renal dysfunction: creatinine \> 2mg/dl
  • patiënts treated with corticoids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Interventions

Methylprednisolone

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Stefaan Bouchez, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 13, 2009

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 7, 2022

Record last verified: 2022-12

Locations

BE(1)