Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion
Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion
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.
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
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…)