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Description of Septic Thrombophlebitis on Central Venous Catheter and Midline (THROMBOSEP)

Primary Purpose

Septic Thrombophlebitis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Doppler ultrasound
Sponsored by
Centre Hospitalier le Mans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Septic Thrombophlebitis focused on measuring septic thrombophlebitis, Doppler ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Angers
  • Centre Hospitalier Le MansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Presence of thrombosis

Absence of thrombosis

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation of duration of ultrasound signs of septic thrombophlebitis on central venous catheter and midline
the duration is measured by time from the day of diagnosis of septic thrombophlebitis to the day of disappearance of signs of thrombophlebitis on Doppler ultrasound

Secondary Outcome Measures

Full Information

First Posted
February 10, 2023
Last Updated
June 14, 2023
Sponsor
Centre Hospitalier le Mans
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1. Study Identification

Unique Protocol Identification Number
NCT05743738
Brief Title
Description of Septic Thrombophlebitis on Central Venous Catheter and Midline
Acronym
THROMBOSEP
Official Title
Description of Septic Thrombophlebitis on Central Venous Catheter and Midline
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier le Mans

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Thrombophlebitis
Keywords
septic thrombophlebitis, Doppler ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Presence of thrombosis
Arm Type
Other
Arm Description
Doppler ultrasound D8, D15, D30, D45, D60 and D90
Arm Title
Absence of thrombosis
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
Doppler ultrasound
Intervention Description
Control venous Doppler ultrasound
Primary Outcome Measure Information:
Title
Evaluation of duration of ultrasound signs of septic thrombophlebitis on central venous catheter and midline
Description
the duration is measured by time from the day of diagnosis of septic thrombophlebitis to the day of disappearance of signs of thrombophlebitis on Doppler ultrasound
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle JADEAU
Phone
+33244710781
Email
cjadeau@ch-lemans.fr
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diama NDIAYE, MD
Phone
02 41 35 33 05
Email
Diama.Ndiaye@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Diama NDIAYE, MD
Facility Name
Centre Hospitalier Le Mans
City
Le Mans
ZIP/Postal Code
72 000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle Jadeau, PD
Phone
02 44 71 07 81
Email
cjadeau@ch-lemans.fr
First Name & Middle Initial & Last Name & Degree
Lucia Grandiere-Perez, MD
Phone
0 (33) 2 43 43 43 43
Email
lperez@ch-lemans.fr
First Name & Middle Initial & Last Name & Degree
Lucia Grandiere-Perez, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Description of Septic Thrombophlebitis on Central Venous Catheter and Midline

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