Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter (TIM-GHM)
Primary Purpose
Intravascular Device
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Midline catheter
Sponsored by

About this trial
This is an interventional other trial for Intravascular Device
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
Sites / Locations
- Groupe Hospitalier Mutualiste de Grenoble
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Midline catheter
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Identification of intravenous treatments - Corticosteroid
Determination of whether corticosteroid are intravenously administered during the day (YES/NO).
Identification of intravenous treatments - Antibiotics
Determination of whether antibiotics are intravenously administered during the day (YES/NO).
Identification of intravenous treatments - Chemotherapy
Determination of whether chemotherapy was intravenously administered during the day (YES/NO).
Identification of intravenous treatments - Nutrient solution
Determination of whether nutrient solution was intravenously administered during the day (YES/NO).
Duration of insertion procedure
Lifetime of catheter
Time from catheter insertion to catheter removal, measured in days.
Body Mass Index
White blood cells count
Incidence of thrombosis
If the catheter is no more permeable, a doppler echocardiography will be done to confirm the diagnosis of thrombosis.
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".
Full Information
NCT ID
NCT03373630
First Posted
November 23, 2017
Last Updated
December 20, 2019
Sponsor
Groupe Hospitalier Mutualiste de Grenoble
Collaborators
TIMC-IMAG, Vygon GmbH & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT03373630
Brief Title
Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter
Acronym
TIM-GHM
Official Title
Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
October 21, 2019 (Actual)
Study Completion Date
October 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier Mutualiste de Grenoble
Collaborators
TIMC-IMAG, Vygon GmbH & Co. KG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intravascular Device
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Midline catheter
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Midline catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of infection of midline catheter
Description
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.
Time Frame
Catheter removal, performed up to 28 days after enrollment
Secondary Outcome Measure Information:
Title
Identification of the germs responsible for infections of midline catheter
Description
For each infected catheter, the species name of the germ responsible for the infection will be collected.
Time Frame
Catheter removal, performed up to 28 days after enrollment
Title
Identification of intravenous treatments - Corticosteroid
Description
Determination of whether corticosteroid are intravenously administered during the day (YES/NO).
Time Frame
Everyday from baseline, up to 28 days
Title
Identification of intravenous treatments - Antibiotics
Description
Determination of whether antibiotics are intravenously administered during the day (YES/NO).
Time Frame
Everyday from baseline, up to 28 days
Title
Identification of intravenous treatments - Chemotherapy
Description
Determination of whether chemotherapy was intravenously administered during the day (YES/NO).
Time Frame
Everyday from baseline, up to 28 days
Title
Identification of intravenous treatments - Nutrient solution
Description
Determination of whether nutrient solution was intravenously administered during the day (YES/NO).
Time Frame
Everyday from baseline, up to 28 days
Title
Duration of insertion procedure
Time Frame
Baseline
Title
Lifetime of catheter
Description
Time from catheter insertion to catheter removal, measured in days.
Time Frame
Catheter removal, performed up to 28 days after enrollment
Title
Body Mass Index
Time Frame
Baseline
Title
White blood cells count
Time Frame
Everyday from baseline, up to 28 days
Title
Incidence of thrombosis
Description
If the catheter is no more permeable, a doppler echocardiography will be done to confirm the diagnosis of thrombosis.
Time Frame
Catheter removal, performed up to 28 days after enrollment
Title
Patient comfort
Description
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".
Time Frame
Every three days from baseline, up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Groupe Hospitalier Mutualiste de Grenoble
City
Grenoble
ZIP/Postal Code
38028
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
9601314
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.
Results Reference
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PubMed Identifier
24440542
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.
Results Reference
background
PubMed Identifier
21906266
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.
Results Reference
background
PubMed Identifier
22947496
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.
Results Reference
background
PubMed Identifier
25331552
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.
Results Reference
background
PubMed Identifier
24811591
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.
Results Reference
background
PubMed Identifier
7486466
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.
Results Reference
background
PubMed Identifier
23295565
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.
Results Reference
background
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Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter
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