Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion

Condition(s) targeted: Pericardial Effusion

Intervention: diclofenac (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: French Cardiology Society

Official(s) and/or principal investigator(s):
Philippe Meurin, MD, Principal Investigator, Affiliation: Les grands Prés; 27 rue Sainte Christine 77174 , Villeneuve Saint Denis, France
Philippe Meurin, MD, Principal Investigator, Affiliation: Les Grands Prés

Overall contact:
philippe Meurin, MD, Phone: 33160435959, Email: philippemeurin@hotmail.com

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.

Official title: the Post Operative Pericardial Effusion (POPE) Treatment Study

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: 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:

 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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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…)

philippe Meurin, MD, Phone: 33160435959, Email: philippemeurin@hotmail.com

Hôpital Broussais, Paris 75014, France; Recruiting
MC ILIOU, MD, Phone: 331439595
MC ILIOU, MD, Principal Investigator

IRIS, Lyon 69, France; Recruiting
Bernard Pierre, MD
bernard Pierre, MD, Principal Investigator

Hôpital Bligny, Briis sous forges 91, France; Recruiting
Sonia Corone, MD
Sonia Corone, MD, Principal Investigator

Les Grands Prés, Villeneuve Saint Denis 77174, France; Recruiting
Philippe Meurin, MD, Phone: 33160435959, Email: philippemeurin@hotmail.com
philippe Meurin, MD, Principal Investigator
jean yves Tabet, MD, Sub-Investigator
Ahmed Ben Driss, MD,PhD, Sub-Investigator
Hélène Weber, MD, Sub-Investigator
Nathalie Renaud, MD, Sub-Investigator

Centre Hospitalier Chateau Lemoine, bordeaux 33000, France; Recruiting
michel fischbach, MD, Phone: 0556371280

Related publications:

Meurin P, Weber H, Renaud N, Larrazet F, Tabet JY, Demolis P, Ben Driss A. Evolution of the postoperative pericardial effusion after day 15: the problem of the late tamponade. Chest. 2004 Jun;125(6):2182-7.

Starting date: March 2006
Ending date: March 2008
Last updated: April 4, 2007