NCT00247052

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2006

Typical duration for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

August 3, 2009

Status Verified

July 1, 2009

Enrollment Period

2.8 years

First QC Date

October 28, 2005

Last Update Submit

July 31, 2009

Conditions

Pericardial Effusion

Keywords

post operative pericardial effusionNSAID

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Number of tamponades

  • Number of patients in whom the individual echographic grade is decreasing of at least one point

  • Number of pericardiotomy

  • Creatinemia

  • Haemoglobinemia

  • +2 more secondary outcomes

Study Arms (2)

diclofenac

ACTIVE COMPARATOR

diclofenac

Drug: diclofenac

2

PLACEBO COMPARATOR
Drug: matching placebo

Interventions

diclofenacDRUG

diclofenac 50 mg bid versus placebo bid

diclofenac
matching placeboDRUG
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cardiac transplantation
  • Age \<18 and \> 80
  • Pregnancy
  • Diclofenac contra indication (allergy, gastro intestinal ulcer, renal insufficiency, cardiac failure…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre Hospitalier Chateau Lemoine

Bordeaux, 33000, France

Location

Hôpital Bligny

Briis-sous-Forges, 91, France

Location

IRIS

Lyon, 69, France

Location

Hôpital Broussais

Paris, 75014, France

Location

Les Grands Prés

Villeneuve-Saint-Denis, 77174, France

Location

Related Publications (2)

  • 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.

    PMID: 15189940BACKGROUND

  • 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.

    PMID: 20124229DERIVED

MeSH Terms

Conditions

Pericardial Effusion

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Philippe Meurin, MD

    Les grands Prés; 27 rue Sainte Christine 77174 , Villeneuve Saint Denis, France

    PRINCIPAL INVESTIGATOR

  • Philippe Meurin, MD

    Les Grands Prés

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 28, 2005

First Posted

November 1, 2005

Study Start

March 1, 2006

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

August 3, 2009

Record last verified: 2009-07

Locations

FR(5)