Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion

Pericardial Effusion Clinical Trial

Official title:

the Post Operative Pericardial Effusion (POPE) Treatment Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247052
• Other study ID #: 2003-06
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2005
• Last updated: July 31, 2009
• Start date: March 2006
• Est. completion date: February 2009

Study information

• Verified date: July 2009
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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…)

Study Design

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

Related Conditions & MeSH terms

• Pericardial Effusion

Intervention

Drug:
• diclofenac
diclofenac 50 mg bid versus placebo bid
• diclofenac
diclofenac 100 mg per day for 14 days
• matching placebo

Locations

Country	Name	City	State
France	Centre Hospitalier Chateau Lemoine	Bordeaux
France	Hôpital Bligny	Briis sous forges
France	IRIS	Lyon
France	Hôpital Broussais	Paris
France	Les Grands Prés	Villeneuve Saint Denis

Sponsors (3)

Lead Sponsor	Collaborator
French Cardiology Society	Clinact, CLIPA

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of tamponades			Yes
Secondary	Number of patients in whom the individual echographic grade is decreasing of at least one point
Secondary	Number of pericardiotomy
Secondary	Creatinemia
Secondary	Haemoglobinemia
Secondary	PE evolution in patients having an inflammatory syndrome (C reactive Protein >30)
Secondary	PE evolution in patients receiving a vitamin K antagonist