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| Sponsor: | French Cardiology Society |
|---|---|
| Collaborators: |
CLIPA CLINACT (data monitoring) |
| Information provided by: | French Cardiology Society |
| ClinicalTrials.gov Identifier: | NCT00247052 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pericardial Effusion |
Drug: diclofenac Drug: matching placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | the Post Operative Pericardial Effusion (POPE) Treatment Study |
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2006 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
diclofenac: Active Comparator
diclofenac
|
Drug: diclofenac
diclofenac 50 mg bid versus placebo bid
Drug: diclofenac
diclofenac 100 mg per day for 14 days
|
| 2: Placebo Comparator | Drug: matching placebo |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| Hôpital Broussais | |
| Paris, France, 75014 | |
| IRIS | |
| Lyon, France, 69 | |
| Hôpital Bligny | |
| Briis sous forges, France, 91 | |
| Les Grands Prés | |
| Villeneuve Saint Denis, France, 77174 | |
| Centre Hospitalier Chateau Lemoine | |
| bordeaux, France, 33000 | |
| Principal Investigator: | Philippe Meurin, MD | Les grands Prés; 27 rue Sainte Christine 77174 , Villeneuve Saint Denis, France |
| Principal Investigator: | Philippe Meurin, MD | Les Grands Prés |
More Information
| Study ID Numbers: | 2003-06 |
| Study First Received: | October 28, 2005 |
| Last Updated: | July 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00247052 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
post operative pericardial effusion NSAID |
|
Anti-Inflammatory Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Diclofenac Enzyme Inhibitors Pericardial Effusion Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |