Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter

Not Applicable

Completed

• Conditions: Intravascular Device
• Interventions: Device: Midline catheter

• Registration Number: NCT03373630
• Lead Sponsor: Groupe Hospitalier Mutualiste de Grenoble

Brief Summary

The Midline catheter is a peripherally-inserted catheter, with the distal tip being placed at or below the level of the axilla. It is a relevant alternative to other catheters in case of limited venous access and long-run perfusions. Moreover, another significant advantage may be the reduction of the risk of infection.

However, the Midline catheter is poorly described in scientific literature, essentially through retrospective and meta analyses including multiple types of catheters (Piccline, CVC, PAC). Therefore, the TIM-GHM study aims to prospectively assess the rate of infections in case of the Midline catheter.

The results of this study could bring a collective benefit in terms of knowledge and reliability of these intravascular devices.

Depending on these results, a randomized, controlled study will be considered, in order to compare the Midline catheter to its main alternative : the Piccline.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-23
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-14
• Study Start: 2018-01-16
• Primary Completion: 2019-10-21
• Study Completion: 2019-10-21
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Age superior or equal to 18 years old
• Intravascular treatment planned for more than 6 days

Exclusion Criteria

• Medical history of mastectomy with bilateral lymphadenectomy
• Peripheral neuropathy
• Upper-Extremity Deep Vein Thrombosis
• Arteriovenous fistula
• Poor condition of the skin of the upper limbs
• Patient in palliative care
• Patient in emergency care
• Patient under guardianship/curatorship
• Pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Midline catheter	Midline catheter	-

Primary Outcome Measures

Name	Time	Method
Incidence of infection of midline catheter	Catheter removal, performed up to 28 days after enrollment	The method used for bacteriologic analyses will be the Brun Buisson Technique. The diagnosis of infection of the catheter will be based on the clinical signs, the catheter bacteriology, the blood culture collected on the patient and the blood culture collected on the catheter.

Secondary Outcome Measures

Name	Time	Method
Body Mass Index	Baseline
Identification of the germs responsible for infections of midline catheter	Catheter removal, performed up to 28 days after enrollment	For each infected catheter, the species name of the germ responsible for the infection will be collected.
Identification of intravenous treatments - Corticosteroid	Everyday from baseline, up to 28 days	Determination of whether corticosteroid are intravenously administered during the day (YES/NO).
Incidence of thrombosis	Catheter removal, performed up to 28 days after enrollment	If the catheter is no more permeable, a doppler echocardiography will be done to confirm the diagnosis of thrombosis.
Patient comfort	Every three days from baseline, up to 28 days	Numeric rating scale will be collected for each of these 3 dimensions : comfort when eating, comfort when moving, comfort for personal hygiene The scale will range from 0 to 10. 0 will mean "very uncomfortable" and 10 will mean "very comfortable".
White blood cells count	Everyday from baseline, up to 28 days
Identification of intravenous treatments - Antibiotics	Everyday from baseline, up to 28 days	Determination of whether antibiotics are intravenously administered during the day (YES/NO).
Identification of intravenous treatments - Chemotherapy	Everyday from baseline, up to 28 days	Determination of whether chemotherapy was intravenously administered during the day (YES/NO).
Identification of intravenous treatments - Nutrient solution	Everyday from baseline, up to 28 days	Determination of whether nutrient solution was intravenously administered during the day (YES/NO).
Duration of insertion procedure	Baseline
Lifetime of catheter	Catheter removal, performed up to 28 days after enrollment	Time from catheter insertion to catheter removal, measured in days.

Trial Locations

Locations (1)

Groupe Hospitalier Mutualiste de Grenoble; 🇫🇷 Grenoble, France