Clinical trial NCT03373630: Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter
Official title: Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravascular Device
Lead sponsor: Groupe Hospitalier Mutualiste de Grenoble
Sponsor class: OTHER
Collaborators: name: TIMC-IMAG
name: Vygon GmbH & Co. KG
First posted: 2017-12-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of infection of midline catheter
timeFrame: Catheter removal, performed up to 28 days after enrollment
Secondary outcomes:
measure: Identification of the germs responsible for infections of midline catheter
timeFrame: Catheter removal, performed up to 28 days after enrollment
measure: Identification of intravenous treatments - Corticosteroid
timeFrame: Everyday from baseline, up to 28 days
measure: Identification of intravenous treatments - Antibiotics
timeFrame: Everyday from baseline, up to 28 days
measure: Identification of intravenous treatments - Chemotherapy
timeFrame: Everyday from baseline, up to 28 days
measure: Identification of intravenous treatments - Nutrient solution
timeFrame: Everyday from baseline, up to 28 days
measure: Duration of insertion procedure
timeFrame: Baseline
measure: Lifetime of catheter
timeFrame: Catheter removal, performed up to 28 days after enrollment
measure: Body Mass Index
timeFrame: Baseline
measure: White blood cells count
timeFrame: Everyday from baseline, up to 28 days
measure: Incidence of thrombosis
timeFrame: Catheter removal, performed up to 28 days after enrollment
measure: Patient comfort
timeFrame: Every three days from baseline, up to 28 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.