A Phase 4 interventional study of diclofenac and diclofenac in Pericardial Effusion, sponsored by French Cardiology Society. Completed at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-08-03.
Sponsored by French Cardiology Society · Phase 4, Interventional, and Treatment
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
27 studies on the registry are indexed under Pericardial Effusion; 5 are open to participants now.
This study's planned enrollment of 200 is above the median of 78 across 22 interventional studies indexed under Pericardial Effusion.
Browse Pericardial Effusion studies →French Cardiology Society is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
diclofenac
Drug: diclofenac
Drug: matching placebo
diclofenac 50 mg bid versus placebo bid
diclofenac 100 mg per day for 14 days
comparison of the evolution between day 1 and day 14 of the mean echocardiographic score of pericardial effusion between treated and untreated (placebo) groups
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
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
French Cardiology Society