Full Text View
Tabular View
No Study Results Posted
Related Studies
Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion
This study is currently recruiting participants.
Verified by French Cardiology Society, April 2007
First Received: October 28, 2005   Last Updated: April 4, 2007   History of Changes
Sponsored by: French Cardiology Society
Information provided by: French Cardiology Society
ClinicalTrials.gov Identifier: NCT00247052
  Purpose

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.


Condition Intervention Phase
Pericardial Effusion
Drug: diclofenac
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: the Post Operative Pericardial Effusion (POPE) Treatment Study

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • comparison of the evolution between day 1 and day 14 of the mean echocardiographic score of pericardial effusion between treated and untreated (placebo) groups

Secondary Outcome Measures:
  •  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

Estimated Enrollment: 200
Study Start Date: March 2006
Estimated Study Completion Date: March 2008
Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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…)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247052

Contacts
Contact: philippe Meurin, MD 33160435959 philippemeurin@hotmail.com

Locations
France
Hôpital Broussais Recruiting
Paris, France, 75014
Contact: MC ILIOU, MD     331439595        
Principal Investigator: MC ILIOU, MD            
IRIS Recruiting
Lyon, France, 69
Contact: Bernard Pierre, MD            
Principal Investigator: bernard Pierre, MD            
Hôpital Bligny Recruiting
Briis sous forges, France, 91
Contact: Sonia Corone, MD            
Principal Investigator: Sonia Corone, MD            
Les Grands Prés Recruiting
Villeneuve Saint Denis, France, 77174
Contact: Philippe Meurin, MD     33160435959     philippemeurin@hotmail.com    
Principal Investigator: philippe Meurin, MD            
Sub-Investigator: jean yves Tabet, MD            
Sub-Investigator: Ahmed Ben Driss, MD,PhD            
Sub-Investigator: Hélène Weber, MD            
Sub-Investigator: Nathalie Renaud, MD            
Centre Hospitalier Chateau Lemoine Recruiting
bordeaux, France, 33000
Contact: michel fischbach, MD     0556371280        
Sponsors and Collaborators
French Cardiology Society
Investigators
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
  More Information

Publications:
Study ID Numbers: 2003-06
Study First Received: October 28, 2005
Last Updated: April 4, 2007
ClinicalTrials.gov Identifier: NCT00247052     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by French Cardiology Society:
post operative pericardial effusion
NSAID

Study placed in the following topic categories:
Anti-Inflammatory Agents
Heart Diseases
Analgesics, Non-Narcotic
Cyclooxygenase Inhibitors
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Pericardial Effusion
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Diclofenac
Enzyme Inhibitors
Pericardial Effusion
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009