Clinical trial NCT00247052: Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion
Official title: the Post Operative Pericardial Effusion (POPE) Treatment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pericardial Effusion
Keywords: post operative pericardial effusion
NSAID
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: CLIPA
name: Clinact
First posted: 2005-11-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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...)

Primary outcomes:
measure: 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 outcomes:
measure: Number of tamponades
measure: Number of patients in whom the individual echographic grade is decreasing of at least one point
measure: Number of pericardiotomy
measure: Creatinemia
measure: Haemoglobinemia
measure: PE evolution in patients having an inflammatory syndrome (C reactive Protein >30)
measure: PE evolution in patients receiving a vitamin K antagonist
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Chateau Lemoine
city: Briis sous forges
country: France
facility: Hôpital Bligny
city: Lyon
country: France
facility: IRIS
city: Paris
country: France
facility: Hôpital Broussais
city: Villeneuve Saint Denis
country: France
facility: Les Grands Prés
Study officials:
affiliation: Les grands Prés; 27 rue Sainte Christine 77174 , Villeneuve Saint Denis, France
name: Philippe Meurin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Les Grands Prés
name: Philippe Meurin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.