Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter (TIM-GHM)

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.

Study Overview

• Status: Completed
• Conditions: Intravascular Device
• Intervention / Treatment: Device: Midline catheter

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38028
    • Groupe Hospitalier Mutualiste de Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Midline catheter	Device: Midline catheter; The catheter will be inserted according to usual practices, after the enrollment of the patient in the study. The follow-up will last until the removal of the catheter, which will also be done according to usual practices. Following the removal, bacteriologic analyses will be performed in order to diagnose any prospective infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of infection of midline catheter	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.	Catheter removal, performed up to 28 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index		Baseline
Identification of the germs responsible for infections of midline catheter	For each infected catheter, the species name of the germ responsible for the infection will be collected.	Catheter removal, performed up to 28 days after enrollment
Identification of intravenous treatments - Corticosteroid	Determination of whether corticosteroid are intravenously administered during the day (YES/NO).	Everyday from baseline, up to 28 days
Identification of intravenous treatments - Antibiotics	Determination of whether antibiotics are intravenously administered during the day (YES/NO).	Everyday from baseline, up to 28 days
Identification of intravenous treatments - Chemotherapy	Determination of whether chemotherapy was intravenously administered during the day (YES/NO).	Everyday from baseline, up to 28 days
Identification of intravenous treatments - Nutrient solution	Determination of whether nutrient solution was intravenously administered during the day (YES/NO).	Everyday from baseline, up to 28 days
Duration of insertion procedure		Baseline
Lifetime of catheter	Time from catheter insertion to catheter removal, measured in days.	Catheter removal, performed up to 28 days after enrollment
White blood cells count		Everyday from baseline, up to 28 days
Incidence of thrombosis	If the catheter is no more permeable, a doppler echocardiography will be done to confirm the diagnosis of thrombosis.	Catheter removal, performed up to 28 days after enrollment
Patient comfort	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".	Every three days from baseline, up to 28 days

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Mutualiste de Grenoble
• Collaborators: TIMC-IMAG; Vygon GmbH & Co. KG

Publications and helpful links

General Publications

• Goetz AM, Miller J, Wagener MM, Muder RR. Complications related to intravenous midline catheter usage. A 2-year study. J Intraven Nurs. 1998 Mar-Apr;21(2):76-80.
• Chopra V, Ratz D, Kuhn L, Lopus T, Chenoweth C, Krein S. PICC-associated bloodstream infections: prevalence, patterns, and predictors. Am J Med. 2014 Apr;127(4):319-28. doi: 10.1016/j.amjmed.2014.01.001. Epub 2014 Jan 17.
• Timsit JF, Dubois Y, Minet C, Bonadona A, Lugosi M, Ara-Somohano C, Hamidfar-Roy R, Schwebel C. New materials and devices for preventing catheter-related infections. Ann Intensive Care. 2011 Aug 18;1:34. doi: 10.1186/2110-5820-1-34.
• Ugas MA, Cho H, Trilling GM, Tahir Z, Raja HF, Ramadan S, Jerjes W, Giannoudis PV. Central and peripheral venous lines-associated blood stream infections in the critically ill surgical patients. Ann Surg Innov Res. 2012 Sep 4;6(1):8. doi: 10.1186/1750-1164-6-8.
• Ziegler MJ, Pellegrini DC, Safdar N. Attributable mortality of central line associated bloodstream infection: systematic review and meta-analysis. Infection. 2015 Feb;43(1):29-36. doi: 10.1007/s15010-014-0689-y. Epub 2014 Oct 21.
• Zochios V, Umar I, Simpson N, Jones N. Peripherally inserted central catheter (PICC)-related thrombosis in critically ill patients. J Vasc Access. 2014 Sep-Oct;15(5):329-37. doi: 10.5301/jva.5000239. Epub 2014 Apr 25.
• Mermel LA, Parenteau S, Tow SM. The risk of midline catheterization in hospitalized patients. A prospective study. Ann Intern Med. 1995 Dec 1;123(11):841-4. doi: 10.7326/0003-4819-123-11-199512010-00005.
• Pongruangporn M, Ajenjo MC, Russo AJ, McMullen KM, Robinson C, Williams RC, Warren DK. Patient- and device-specific risk factors for peripherally inserted central venous catheter-related bloodstream infections. Infect Control Hosp Epidemiol. 2013 Feb;34(2):184-9. doi: 10.1086/669083. Epub 2012 Dec 14.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2018
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): October 21, 2019

Study Registration Dates

• First Submitted: November 23, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): December 23, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 2017/11-DFO-GHMG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No