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
  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
Drug: matching placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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 [ 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

Estimated Enrollment: 200
Study Start Date: March 2006
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: diclofenac
diclofenac
Drug: diclofenac
diclofenac 50 mg bid versus placebo bid
Drug: diclofenac
diclofenac 100 mg per day for 14 days
Placebo Comparator: 2 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247052

Locations
France
Centre Hospitalier Chateau Lemoine
Bordeaux, France, 33000
Hôpital Bligny
Briis sous forges, France, 91
IRIS
Lyon, France, 69
Hôpital Broussais
Paris, France, 75014
Les Grands Prés
Villeneuve Saint Denis, France, 77174
Sponsors and Collaborators
French Cardiology Society
CLIPA
Clinact
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00247052     History of Changes
Other Study ID Numbers: 2003-06
Study First Received: October 28, 2005
Last Updated: July 31, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on August 25, 2014