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Completed

NCT Number: NCT03373630

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

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.

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Key information

Conditions

Intravascular Device

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of infection of midline catheter

    Time frame: 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 outcomes

  1. Identification of the germs responsible for infections of midline catheter

    Time frame: 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.

  2. Identification of intravenous treatments - Corticosteroid

    Time frame: Everyday from baseline, up to 28 days

    Determination of whether corticosteroid are intravenously administered during the day (YES/NO).

  3. Identification of intravenous treatments - Antibiotics

    Time frame: Everyday from baseline, up to 28 days

    Determination of whether antibiotics are intravenously administered during the day (YES/NO).

  4. Identification of intravenous treatments - Chemotherapy

    Time frame: Everyday from baseline, up to 28 days

    Determination of whether chemotherapy was intravenously administered during the day (YES/NO).

  5. Identification of intravenous treatments - Nutrient solution

    Time frame: Everyday from baseline, up to 28 days

    Determination of whether nutrient solution was intravenously administered during the day (YES/NO).

  6. Duration of insertion procedure

    Time frame: Baseline

  7. Lifetime of catheter

    Time frame: Catheter removal, performed up to 28 days after enrollment

    Time from catheter insertion to catheter removal, measured in days.

  8. Body Mass Index

    Time frame: Baseline

  9. White blood cells count

    Time frame: Everyday from baseline, up to 28 days

  10. Incidence of thrombosis

    Time frame: 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.

  11. Patient comfort

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Mutualiste de Grenoble

Other

Collaborators

  • TIMC-IMAG
  • Vygon GmbH & Co. KG

Registry information

Acronym: TIM-GHM

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2017
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.