Comparison of Early Phase Infections Risk Between Midline and Piccline Caheters: MIDLINE AND PICCLINE CATHETERS

Catheter-related Bloodstream Infection Clinical Trial

— PICCORMID  

Official title:

Comparison of Early Phase Infections Risk Between Midline and Piccline Caheters: MIDLINE AND PICCLINE CATHETERS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05264402
• Other study ID #: PICCORMID (29BRC21.0288)
• Status: Recruiting
• Start date: November 15, 2021
• Est. completion date: November 2022

Study information

• Verified date: January 2022
• Source: University Hospital, Brest
• Contact: AnaÏS CAILLARD
• Phone: 02 98 34 72 88
• Email: anais.caillard[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A long-term venous access is frequently required in patient management. Currently, it is ensured by using the long peripheral intravenous catheters (Midline) or peripheral inserted central catheters (PICC line). Either is inserted into a peripheral vein of the upper arm and extends to the distal axillary vein.

If the indications for the two catheters can sometimes be debated, the Midline catheter seems to be more and more used. The complications related to the use of PICC lines have been well described in literature, whereas the comparison of the two catheter-related complications has been less analysed.

The aim of this study is to compare the incidences of catheter-related bloodstream infections linked to PICCs and Midlines.

Description:

This single-center observational study will record and compare Midline and PICC line catheter-related bloodstream infections in the first 30 days after placement, catheter-related bloodstream infections being defined as clinical signs associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points.

Catheter indications, insertion conditions, incidence of haemorrhagic and thrombotic complications during the first 30 days will be analyzed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major = 18 years old

• opposition formulated

Exclusion Criteria:

• Refusal of participation

• Patients under legal protection (guardianship, curatorship, etc.)

Related Conditions & MeSH terms

• Catheter-related Bloodstream Infection
• Communicable Diseases
• Infections
• Sepsis

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compared rate of catheter-related bloodstream infections in the first 30 days in Midline and PICCline group. Catheter-related bloodstream infections are defined as clinical signs with a positive catheter culture without any other infectious entry points.	catheter-related bloodstream infections being defined as clinical signs (fever, swelling, pain) associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points.; the number of infections recorded will be compared between the group of patients having a Midline and the group of patients having a PICCline	first 30 days after placement
Secondary	catheter placement time will be evaluated in days	catheter placement time will be evaluted by measuring the time between catheter placement and removal in days	first 30 days after placement
Secondary	rate of no infection complications like obstruction, accidental removal, thrombosis, hemorrhagic complications	The number of mechanical compliaction (obstruction, accidental removal, etc.), haemorrhagic and thrombotic complications recorded will be compared between the group of patients having a Midline and the group of patients having a PICCline	first 30 days