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

NCT03373630 | Completed

• 1 other identifier: 2017/11-DFO-GHMG
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravascular Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Identification of the germs responsible for infections of midline catheter

  Catheter removal, performed up to 28 days after enrollment

• Identification of intravenous treatments - Corticosteroid

  Everyday from baseline, up to 28 days

• Identification of intravenous treatments - Antibiotics

  Everyday from baseline, up to 28 days

• Identification of intravenous treatments - Chemotherapy

  Everyday from baseline, up to 28 days

• Identification of intravenous treatments - Nutrient solution

  Everyday from baseline, up to 28 days

Study Arms (1)

Midline catheter

EXPERIMENTAL

Device: Midline catheter

Interventions

Midline catheter DEVICE

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.

Midline catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier Mutualiste de Grenoble: lead
• TIMC-IMAG: collaborator
• Vygon GmbH & Co. KG: collaborator

Study Sites (1)

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

Location

Related Publications (8)

• 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.

  PMID: 9601314 BACKGROUND

• 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.

  PMID: 24440542 BACKGROUND

• 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.

  PMID: 21906266 BACKGROUND

• 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.

  PMID: 22947496 BACKGROUND

• 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.

  PMID: 25331552 BACKGROUND

• 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.

  PMID: 24811591 BACKGROUND

• 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.

  PMID: 7486466 BACKGROUND

• 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.

  PMID: 23295565 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: December 14, 2017
• Study Start: January 16, 2018
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)