Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion (VIDMED)
Primary Purpose
Infectious Pleural Effusion
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Videothoracoscopy drainage
Medical drainage
Sponsored by
About this trial
This is an interventional treatment trial for Infectious Pleural Effusion
Eligibility Criteria
Inclusion Criteria:
- Infectious pleural effusion diagnosed by pleural punction with biologic features of infection: C Reactive Protein level >5 mg/L, White cells counts > 10000 G/L, Temperature >38°c, effusion with a ph<7,2 or presence of polynuclear, and radiologic features of effusion requiring drainage (>1/5 thoracic volume)
Exclusion Criteria:
- prior thoracic surgery, past history of pleural effusion
- compressive effusion which should be treated in emergency
- Pregnancy
- No acceptance of the protocol by the informed patient
Sites / Locations
- University HospitalRecruiting
- University Hospital
- UH RouenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
videothoracoscopy drainage
Medical pleural drainage
Arm Description
videothoracoscopy drainage of pleural effusion
Medical drainage
Outcomes
Primary Outcome Measures
Hospital Stay in days
Secondary Outcome Measures
Full Information
NCT ID
NCT01994499
First Posted
October 30, 2013
Last Updated
October 7, 2016
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT01994499
Brief Title
Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion
Acronym
VIDMED
Official Title
Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Infectious pleural effusion is a classic complication of pneumonia and often require pleural drainage.
There is no consensus between surgical drainage and medical drainage indication in first intention to treat an empyema.
Usually surgery is proposed in second intention after failure of medical drainage.
Videothoracoscopy is well accepted in diagnosis and treatment of pleural pathologies. The morbidity of this approach is very low with good results and become the gold standard in different pleural diseases. The medical drainage can be also very efficient but its results depends of the evolution of the pleural effusion. The rate of failure is estimated around 25%.
Then, the aim of our study is to compare surgical drainage and medical drainage in first intention. The first end-point will be the hospital stay (day). Hospital discharge will be strict, following different objective criteria of healing allowing comparison between these two approaches of drainage.
To answer this question we will randomized 50 patients in 2 years with a multicenter recruitment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Pleural Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
videothoracoscopy drainage
Arm Type
Experimental
Arm Description
videothoracoscopy drainage of pleural effusion
Arm Title
Medical pleural drainage
Arm Type
Active Comparator
Arm Description
Medical drainage
Intervention Type
Device
Intervention Name(s)
Videothoracoscopy drainage
Intervention Description
videothoracoscopy drainage of pleural effusion
Intervention Type
Drug
Intervention Name(s)
Medical drainage
Intervention Description
Medical pleural drainage
Primary Outcome Measure Information:
Title
Hospital Stay in days
Time Frame
patients will be followed for the duration of the hopital stay, an expected average of 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infectious pleural effusion diagnosed by pleural punction with biologic features of infection: C Reactive Protein level >5 mg/L, White cells counts > 10000 G/L, Temperature >38°c, effusion with a ph<7,2 or presence of polynuclear, and radiologic features of effusion requiring drainage (>1/5 thoracic volume)
Exclusion Criteria:
prior thoracic surgery, past history of pleural effusion
compressive effusion which should be treated in emergency
Pregnancy
No acceptance of the protocol by the informed patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jean-marc Baste, MD
Phone
232888990
Ext
0033
Email
jean-marc.baste@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jean-marc baste, MD
Organizational Affiliation
University Hospital Rouen, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
pascal berna, MD
Facility Name
University Hospital
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
gerard Zachmann, Prof
Facility Name
UH Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean M BASTE, MD
First Name & Middle Initial & Last Name & Degree
Jean M BASTE, MD
12. IPD Sharing Statement
Learn more about this trial
Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion
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