Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion
Primary Purpose
Pericardial Effusion
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
diclofenac
diclofenac
matching placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pericardial Effusion focused on measuring post operative pericardial effusion, NSAID
Eligibility Criteria
Inclusion Criteria: -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 > or equal to 2 (that is to say loculated effusion >10 millimeters or circumferential effusion > 1 mm ) will be included Exclusion Criteria: Cardiac transplantation Age <18 and > 80 Pregnancy Diclofenac contra indication (allergy, gastro intestinal ulcer, renal insufficiency, cardiac failure…)
Sites / Locations
- Centre Hospitalier Chateau Lemoine
- Hôpital Bligny
- IRIS
- Hôpital Broussais
- Les Grands Prés
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
diclofenac
2
Arm Description
diclofenac
Outcomes
Primary Outcome Measures
comparison of the evolution between day 1 and day 14 of the mean echocardiographic score of pericardial effusion between treated and untreated (placebo) groups
Secondary Outcome Measures
Number of tamponades
Number of patients in whom the individual echographic grade is decreasing of at least one point
Number of pericardiotomy
Creatinemia
Haemoglobinemia
PE evolution in patients having an inflammatory syndrome (C reactive Protein >30)
PE evolution in patients receiving a vitamin K antagonist
Full Information
NCT ID
NCT00247052
First Posted
October 28, 2005
Last Updated
July 31, 2009
Sponsor
French Cardiology Society
Collaborators
CLIPA, Clinact
1. Study Identification
Unique Protocol Identification Number
NCT00247052
Brief Title
Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion
Official Title
the Post Operative Pericardial Effusion (POPE) Treatment Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
French Cardiology Society
Collaborators
CLIPA, Clinact
4. Oversight
5. Study Description
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 (diclofenac)for 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pericardial Effusion
Keywords
post operative pericardial effusion, NSAID
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
diclofenac
Arm Type
Active Comparator
Arm Description
diclofenac
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
diclofenac
Intervention Description
diclofenac 50 mg bid versus placebo bid
Intervention Type
Drug
Intervention Name(s)
diclofenac
Intervention Description
diclofenac 100 mg per day for 14 days
Intervention Type
Drug
Intervention Name(s)
matching placebo
Primary Outcome Measure Information:
Title
comparison of the evolution between day 1 and day 14 of the mean echocardiographic score of pericardial effusion between treated and untreated (placebo) groups
Secondary Outcome Measure Information:
Title
Number of tamponades
Title
Number of patients in whom the individual echographic grade is decreasing of at least one point
Title
Number of pericardiotomy
Title
Creatinemia
Title
Haemoglobinemia
Title
PE evolution in patients having an inflammatory syndrome (C reactive Protein >30)
Title
PE evolution in patients receiving a vitamin K antagonist
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-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 > or equal to 2 (that is to say loculated effusion >10 millimeters or circumferential effusion > 1 mm ) will be included
Exclusion Criteria:
Cardiac transplantation
Age <18 and > 80
Pregnancy
Diclofenac contra indication (allergy, gastro intestinal ulcer, renal insufficiency, cardiac failure…)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Meurin, MD
Organizational Affiliation
Les grands Prés; 27 rue Sainte Christine 77174 , Villeneuve Saint Denis, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe Meurin, MD
Organizational Affiliation
Les Grands Prés
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Chateau Lemoine
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpital Bligny
City
Briis sous forges
ZIP/Postal Code
91
Country
France
Facility Name
IRIS
City
Lyon
ZIP/Postal Code
69
Country
France
Facility Name
Hôpital Broussais
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Les Grands Prés
City
Villeneuve Saint Denis
ZIP/Postal Code
77174
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
15189940
Citation
Meurin P, Weber H, Renaud N, Larrazet F, Tabet JY, Demolis P, Ben Driss A. Evolution of the postoperative pericardial effusion after day 15: the problem of the late tamponade. Chest. 2004 Jun;125(6):2182-7. doi: 10.1378/chest.125.6.2182.
Results Reference
background
PubMed Identifier
20124229
Citation
Meurin P, Tabet JY, Thabut G, Cristofini P, Farrokhi T, Fischbach M, Pierre B, Driss AB, Renaud N, Iliou MC, Weber H; French Society of Cardiology. Nonsteroidal anti-inflammatory drug treatment for postoperative pericardial effusion: a multicenter randomized, double-blind trial. Ann Intern Med. 2010 Feb 2;152(3):137-43. doi: 10.7326/0003-4819-152-3-201002020-00004.
Results Reference
derived
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Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion
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