Pericardial Effusion Clinical Trial
Official title:
the Post Operative Pericardial Effusion (POPE) Treatment Study
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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