- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03329768
Evaluation of Medical Device
June 2, 2023 updated by: Assistance Publique Hopitaux De Marseille
Evaluation of Peripheral Intravenous Catheter and Urinary Catheters Present on Admission to the "Maladies Infectieuses aiguës" Department.
A preliminary study was conducted from 01/26/2015 to 10/26/2015 on 605 patients admitted to MIA with an intravenous and/or a urinary catheter.
the investigators analyzed:
- the demographic characteristics of the patient
- the final diagnosis
- the patient's severity and the patient outcome after discharge from MIA
- the justification of the venous and or a urinary catheter
- the duration of the prescription of the device Evaluation on admission of the need to maintain an intravenous or urinary catheter. Adjusting the prescription in terms of duration or withdrawal of the device in order to limit their complications (lymphangitis, superficial thrombophlebitis, bacteremia related to health care, urinary tract infection).
Hypothesis:
Limit the length of stay and reduce the cost of hospitalization.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patient with an intravenous and/or urinary catheter on admission in the department of "Maladies infectieuses aigues" (MIA) Hopital de la Timone AP-HM.
Description
Inclusion Criteria:
- Patient with an intravenous catheter and/or a urinary catheter.
- Patient is more than 18 years old.
- Patient who accepts to have his medical records reviewed for research.
- Patient with health insurance
Exclusion Criteria:
- Refusal of participation in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number of patients with intravenous catheter
Time Frame: 3 YEARS
|
3 YEARS
|
|
number of patients with urinary catheter
Time Frame: 3 YEARS
|
3 YEARS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: jean-olivier ARNAUD, Assistance Publique Hopitaux de Marseille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 28, 2016
Primary Completion (Actual)
January 25, 2020
Study Completion (Actual)
June 2, 2023
Study Registration Dates
First Submitted
October 25, 2017
First Submitted That Met QC Criteria
October 30, 2017
First Posted (Actual)
November 6, 2017
Study Record Updates
Last Update Posted (Actual)
June 5, 2023
Last Update Submitted That Met QC Criteria
June 2, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-15
- 2016-A00673-48 (Other Identifier: IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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