Description of Septic Thrombophlebitis on Central Venous Catheter and Midline

NCT ID: NCT05743738

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2026-06-30

Brief Summary

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Central venous catheters improve the tolerability and feasibility of patient care in the hospital setting by allowing the administration of hyper-osmotic, vesicant and venotoxic fluids. Despite these advantages, the long-term presence of central venous catheters is associated with thrombotic and infectious risks , including catheter-related bacteremia, which can be complicated by septic thrombophlebitis and endocarditis that can lead to death.

Septic thrombophlebitis is a complication of venous catheter infections, which increases the morbidity. It is defined by the presence of a thrombosis in the vein where the venous catheter is located, associated with a bacteremia. A distinction is made between superficial and deep thrombophlebitis.

The frequency of septic thrombophlebitis of venous catheters is variable and poorly described in the literature.

When the diagnosis of septic thrombophlebitis is made, it is recommended to extend the duration of antibiotic therapy, to remove the infected catheter and to prescribe anticoagulant treatment. However, there is no recommendation on the duration of anticoagulation for septic thrombophlebitis, whether it is deep or superficial.

Investigator proposes a prospective and descriptive interventional study to describe the ultrasound evolution of thrombus in patients with septic thrombophlebitis on central venous catheter and midline.

Detailed Description

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Conditions

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Septic Thrombophlebitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Presence of thrombosis

Doppler ultrasound D8, D15, D30, D45, D60 and D90

Group Type OTHER

Doppler ultrasound

Intervention Type DIAGNOSTIC_TEST

Control venous Doppler ultrasound

Absence of thrombosis

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Doppler ultrasound

Control venous Doppler ultrasound

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adult patient hospitalised at the CHM or CHUA, with a central venous device (Implantable chamber, central venous jugular, femoral, subclavian, PICCline, dialysis catheter) or a Midline and having catheter-related bacteremia
* Catheter-related bacteremia according to the following definition (ePOPI): Positive blood cultures within 48 hours of a suspected catheter infection (or its removal) With one of the following criteria: - Before catheter removal: differential time of positivity of central/peripheral blood cultures ≥ 2 hours
* After catheter removal: positive catheter culture ≥ 103 CFU/ml, with the same organism.
* Patient transportable for ultrasound or ultrasound can be performed in the patient's bed
* Patient capable of giving consent, or consent of the trusted person for patients not capable of giving consent at the time of inclusion
* Written consent signed by the participant and the investigator
* Person affiliated to social security

Exclusion Criteria

* Patient with a life expectancy of less than one month
* Contraindication to anticoagulation
* Patient already on curative anticoagulant therapy for any indication
* Minor or adult patient under guardianship or protected or deprived of liberty
* Pregnant, nursing or parturient woman
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier le Mans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Angers

Angers, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Le Mans

Le Mans, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christelle JADEAU

Role: CONTACT

+33244710781

Facility Contacts

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Diama NDIAYE, MD

Role: primary

02 41 35 33 05

Christelle Jadeau, PD

Role: primary

02 44 71 07 81

Lucia Grandiere-Perez, MD

Role: backup

0 (33) 2 43 43 43 43

Other Identifiers

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CHM-2020/S10/14

Identifier Type: -

Identifier Source: org_study_id

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