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.

Study Overview

• Status: Completed
• Conditions: Pericardial Effusion
• Intervention / Treatment: Drug: diclofenac; Drug: diclofenac; Drug: matching placebo

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

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Centre Hospitalier Chateau Lemoine
  • Briis sous forges, France, 91
    • Hôpital Bligny
  • Lyon, France, 69
    • IRIS
  • Paris, France, 75014
    • Hôpital Broussais
  • Villeneuve Saint Denis, France, 77174
    • Les Grands Prés

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2	Drug: matching placebo
Active Comparator: diclofenac	Drug: diclofenac; diclofenac 50 mg bid versus placebo bid; Drug: diclofenac; diclofenac 100 mg per day for 14 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: French Cardiology Society
• Collaborators: Clinact; CLIPA
• 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

Publications and helpful links

General 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. doi: 10.1378/chest.125.6.2182.
• Meurin P, Tabet JY, Thabut G, Cristofini P, Farrokhi T, Fischbach M, Pierre B, Driss AB, Renaud N, Iliou MC, Weber H; French Society of Cardiology. Nonsteroidal anti-inflammatory drug treatment for postoperative pericardial effusion: a multicenter randomized, double-blind trial. Ann Intern Med. 2010 Feb 2;152(3):137-43. doi: 10.7326/0003-4819-152-3-201002020-00004.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: October 28, 2005
• First Submitted That Met QC Criteria: October 28, 2005
• First Posted (Estimate): November 1, 2005

Study Record Updates

• Last Update Posted (Estimate): August 3, 2009
• Last Update Submitted That Met QC Criteria: July 31, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: NSAID; post operative pericardial effusion
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pericardial Effusion; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: 2003-06