Pericardial EffusionPhase 4NCT00247052
Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion
A Phase 4 study testing diclofenac in people with Pericardial Effusion, run by French Cardiology Society at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pericardial Effusion
- What is being tested?
- diclofenac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 5 sitesFrance
- Study dates
- Mar 2006to Feb 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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
Who cannot join
- Cardiac transplantation
- Age <18 and > 80
- Pregnancy
- Diclofenac contra indication (allergy, gastro intestinal ulcer, renal insufficiency, cardiac failure…)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Hospitalier Chateau Lemoine
Bordeaux, 33000
Hôpital Bligny
Briis-sous-Forges, 91
IRIS
Lyon, 69
Hôpital Broussais
Paris, 75014
Les Grands Prés
Villeneuve-Saint-Denis, 77174
About this study
Official title: 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.
Read the 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
- Conditions
- Pericardial Effusion
- Being tested
- diclofenac, matching placebo
- Keywords
- post operative pericardial effusion, NSAID
- Medical subject headings
- Pericardial Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenacDrug
diclofenac 50 mg bid versus placebo bid
diclofenacDrug
diclofenac 100 mg per day for 14 days
matching placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| diclofenac | Active comparator | diclofenac Receives: Drug: diclofenac |
| 2 | Placebo comparator | Not described Receives: Drug: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
PE evolution in patients having an inflammatory syndrome (C reactive Protein >30)
PE evolution in patients receiving a vitamin K antagonist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startMar 2006
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pericardial EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- CLIPA, Clinact
- Investigators
- Philippe Meurin, MD, Principal investigator, Les grands Prés; 27 rue Sainte Christine 77174 , Villeneuve Saint Denis, FrancePhilippe Meurin, MD, Principal investigator, Les Grands Prés
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247052
- Sponsor's protocol ID
- 2003-06
- Status last verified
- Jul 2009
- First submitted
- 28 Oct 2005
- Last updated
- 3 Aug 2009
- Results posted
- No
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.
PubMed 15189940Meurin 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.
PubMed 20124229
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Post Operative Pericardial Effusion (POPE) Treatment Study
- ClinicalTrials.gov ID
- NCT00247052
- Acronym / sponsor ID
- 2003-06
- Conditions
- Pericardial Effusion
- Keywords
- post operative pericardial effusion, NSAID
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- CLIPA, Clinact
- Study start
- Mar 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 1 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diclofenac | Active comparator | Drug: diclofenacdiclofenac |
| 2 | Placebo comparator | Drug: matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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
Key exclusion criteria (4 listed)
- Cardiac transplantation
- Age <18 and > 80
- Pregnancy
- Diclofenac contra indication (allergy, gastro intestinal ulcer, renal insufficiency, cardiac failure…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diclofenacdiclofenac 50 mg bid versus placebo bid | Drug | diclofenac |
| diclofenacdiclofenac 100 mg per day for 14 days | Drug | diclofenac |
| matching placebo | Drug | 2 |
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2009.
- Background: PubMed 15189940Meurin 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.
- Derived from this study: PubMed 20124229Meurin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Meurin, MD principal investigator
Les grands Prés; 27 rue Sainte Christine 77174 , Villeneuve Saint Denis, France
Philippe Meurin, MD principal investigator
Les Grands Prés
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing diclofenac in people with Pericardial Effusion, run by French Cardiology Society at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00247052, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2009.