Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247052
Status:
COMPLETED
Last Update Posted:
2009-08-03
First Post:
2005-10-28
Brief Title:
Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion
Sponsor:
French Cardiology Society
Organization:
French Cardiology Society
Study Overview
Official Title:
the Post Operative Pericardial Effusion POPE Treatment Study
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the sudy is to evaluate through clinical biological and transthoracic echocardiography follow up the evolution of post operative cardiac surgery pericardial effusion and mostly to evaluate the efficiency of a non steroidal anti inflammatory NSAID drug diclofenacfor this indication
Detailed Description:
Following cardiac surgery the incidence of Pericardial effusion PE is high 50-85 The risk of tamponade is well acknowledged about 2 We published in 2004 in CHEST a study which allows us to know the natural history of post-operative PE and to validate for the first time the use of an echocardiographic classification for predicting the occurrence of a tamponade NSAID are widely used in this setting but no study has ever been conducted trying to assess their efficiency The aim of the study is therefore obvious must we use NSAID in order to prevent post operative cardiac tamponades
In order to answer this question we are going to conduct a double-blind randomized study comparing diclofenac to a placebo
Every patient hospitalized in a post operative cardiac rehabilitation center less than 30 days after cardiac surgery and presenting at the first TTE Trans Thoracic cardiac Echography a PE of severity 2 that is to say about 10 of the totality of the patients having undergone a cardiac operation will be included after randomisation patients will receive a placebo or diclofenac 50 mg bid in a double blind way during 14 days
Trans thoracic cardiac echography creatininemia haemoglobinemia International Normalized Ratio for patients receiving a vitamin K antagonist will be performed once a week during 2 weeks
Clinical assessment will be done every day there will be no outpatient
Primary end point evolution of the mean echocardiographic score in each group
-Secondary end-points
Number of tamponades Number of patients in whom the individual echographic grade is decreasing of at least one point Number of pericardiotomy Creatininemia Haemoglobinemia PE evolution in patients having an inflammatory syndrome C reactive Protein 30 PE evolution in patients receiving a vitamin K antagonist
86 patients per group are necessary therefore we will include a total of 200 patients
In order to answer this question we are going to conduct a double-blind randomized study comparing diclofenac to a placebo
Every patient hospitalized in a post operative cardiac rehabilitation center less than 30 days after cardiac surgery and presenting at the first TTE Trans Thoracic cardiac Echography a PE of severity 2 that is to say about 10 of the totality of the patients having undergone a cardiac operation will be included after randomisation patients will receive a placebo or diclofenac 50 mg bid in a double blind way during 14 days
Trans thoracic cardiac echography creatininemia haemoglobinemia International Normalized Ratio for patients receiving a vitamin K antagonist will be performed once a week during 2 weeks
Clinical assessment will be done every day there will be no outpatient
Primary end point evolution of the mean echocardiographic score in each group
-Secondary end-points
Number of tamponades Number of patients in whom the individual echographic grade is decreasing of at least one point Number of pericardiotomy Creatininemia Haemoglobinemia PE evolution in patients having an inflammatory syndrome C reactive Protein 30 PE evolution in patients receiving a vitamin K antagonist
86 patients per group are necessary therefore we will include a total of 200 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None