Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00247052
Study type Interventional
Source French Cardiology Society
Contact
Status Completed
Phase Phase 4
Start date March 2006
Completion date February 2009

See also
  Status Clinical Trial Phase
Completed NCT02045641 - Pleural and Pericardial Effusion Following Open Heart Surgery N/A
Completed NCT03327688 - Point-of-care Ultrasound in Finland N/A
Completed NCT02808897 - Active Clearance of Chest Tubes After Cardiac Surgery: A Prospective Randomized Controlled Study N/A
Not yet recruiting NCT06293924 - Pericardial Fluid Analysis in Recurrent Pericarditis
Active, not recruiting NCT01552187 - COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial) Phase 3
Completed NCT05061914 - Surgical Options for Management of Pericardial Effusion N/A
Completed NCT00684125 - Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery N/A
Completed NCT02260206 - Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion Phase 4
Recruiting NCT05146492 - Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM) N/A
Active, not recruiting NCT05077111 - A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia Phase 4
Recruiting NCT02673879 - IMPI 2 - A Trial of Intrapericardial Alteplase in Large Pericardial Effusion Phase 3
Recruiting NCT01665495 - Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention N/A
Recruiting NCT04464655 - A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Recruiting NCT06159985 - Effect of Left Posterior Pericardiotomy for the Prevention of POAF N/A
Completed NCT01266694 - Cochicine Treatment for Post- Operative Pericardial Effusion Phase 4
Recruiting NCT04279327 - Cell Block Immunohistochemistry in Effusion Cytology
Completed NCT03887286 - Focused Cardiac Ultrasound N/A