Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion

This study has been completed.
Sponsor:
Collaborators:
CLIPA
Clinact
Information provided by:
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT00247052
First received: October 28, 2005
Last updated: July 31, 2009
Last verified: July 2009

October 28, 2005
July 31, 2009
March 2006
December 2008   (final data collection date for primary outcome 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
Same as current
Complete list of historical versions of study NCT00247052 on ClinicalTrials.gov Archive Site
  • Number of tamponades [ Designated as safety issue: Yes ]
  • 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
  •  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
Not Provided
Not Provided
 
Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion
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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pericardial Effusion
  • Drug: diclofenac
    diclofenac 50 mg bid versus placebo bid
  • Drug: diclofenac
    diclofenac 100 mg per day for 14 days
  • Drug: matching placebo
  • Active Comparator: diclofenac
    diclofenac
    Interventions:
    • Drug: diclofenac
    • Drug: diclofenac
  • Placebo Comparator: 2
    Intervention: Drug: matching placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
February 2009
December 2008   (final data collection date for primary outcome measure)

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…)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00247052
2003-06
Not Provided
Not Provided
French Cardiology Society
  • CLIPA
  • Clinact
Principal Investigator: Philippe Meurin, MD Les grands Prés; 27 rue Sainte Christine 77174 , Villeneuve Saint Denis, France
Principal Investigator: Philippe Meurin, MD Les Grands Prés
French Cardiology Society
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP