Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cochicine Treatment for Post- Operative Pericardial Effusion

NCT01266694

Pericardial Effusion

COMPLETED PHASE4

A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)

NCT00234104

Heart Failure, Congestive Edema

COMPLETED PHASE2

COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial)

NCT01552187

Cardiac Surgery Post-pericardiotomy Syndrome Atrial Fibrillation +2 more

UNKNOWN PHASE3

Safety and Efficacy of FAP iCDC in End-stage Dilated Cardiomyopathy

NCT06902896

Dilated Cardiomyopathy (DCM) Heart Failure

NOT_YET_RECRUITING PHASE1

Study of Dapansutrile Capsules in Heart Failure

NCT03534297

Systolic Heart Failure

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pericardial Effusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

diclofenac

Group Type ACTIVE_COMPARATOR

diclofenac

Intervention Type DRUG

diclofenac 50 mg bid versus placebo bid

diclofenac

Intervention Type DRUG

diclofenac 100 mg per day for 14 days

2

Group Type PLACEBO_COMPARATOR

matching placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

diclofenac

diclofenac 50 mg bid versus placebo bid

Intervention Type DRUG

diclofenac

diclofenac 100 mg per day for 14 days

Intervention Type DRUG

matching placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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…)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No