Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Medical Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03329768
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

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.


Condition or disease
Acute Infectious Diseases

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Peripheral Intravenous Catheter and Urinary Catheters Present on Admission to the "Maladies Infectieuses aiguës" Department.
Actual Study Start Date : September 28, 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : March 2020



Primary Outcome Measures :
  1. number of patients with intravenous catheter [ Time Frame: 3 YEARS ]
  2. number of patients with urinary catheter [ Time Frame: 3 YEARS ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329768


Contacts
Layout table for location contacts
Contact: philippe parola philippe.parola@ap-hm.fr

Locations
Layout table for location information
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: PHILIPPE PAROLA       philippe.parola@ap-hm.fr   
Principal Investigator: philippe parola         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Layout table for investigator information
Study Director: jean-olivier ARNAUD Assistance Publique Hopitaux De Marseille

Layout table for additonal information
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03329768     History of Changes
Other Study ID Numbers: 2016-15
2016-A00673-48 ( Other Identifier: IDRCB )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Infection