Prospective Evaluation of Complications of MidLine Cathet... | NCT05412108

Studies
Prospective Evaluation of Complications of MidLine Catheters in the ICU

NCT05412108

Sponsor

Centre Hospitalier le Mans

Status

Completed

Last Update Posted

Jul 1, 2026Actual

Enrollment

148Actual

Phase

Not provided

Conditions

Catheter Complications

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2022Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

May 31, 2022

First Submission Date that Met QC Criteria

Jun 7, 2022

First Posted Date

Jun 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2026

Last Update Posted Date

Jul 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Midline catheters (MCs) are peripheral catheters inserted into a vein in the arm above the elbow crease, with the tip in the axillary vein. As such, they do not enter the central venous circulation and are therefore not considered central venous catheters.

The main complications associated with CM are accidental removal, leakage, subcutaneous diffusion and occlusion. Severe complications include deep vein thrombosis (DVT) and catheter-related bacteremia (CRB). There is very little data on the use of CMs in intensive care units (ICU).

Resuscitation patients are more likely to develop severe catheter-related complications such as deep vein thrombosis and catheter-related infections. While the use of CMs in patients appears to be associated with a low risk of complications, this may not be the case in resuscitation patients.

Investigator therefore proposes to conduct a prospective observational study to determine the frequency and type of complications associated with CMs when they are implanted and used in ICU. In addition, investigator will attempt to determine whether risk factors predictive of complications can be identified. In addition, this study will evaluate whether the use of CMs can reduce the duration of central venous catheter maintenance in the ICU and the risk of central venous catheter-related infections.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

148Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Describe the incidence of severe complications associated with the use of CMs in ICUs	The severe complications identified will be symptomatic deep vein thrombosis, symptomatic pulmonary embolism, catheter-related infections	From midline catheter placement to hospital discharge (up to 28 days)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ICU Hospitalization
Indication for MidLine catheter placement during the stay

Exclusion Criteria:

Minor or protected adult
Pregnant woman
Local contraindication to the placement of a CM
- Local infection
- Venous thrombosis
- Existing arteriovenous fistula or vascular network to be protected for a fistula for chronic dialysis
- Paralysis of the limb
Need for administration of contraindicated solutions on the peripheral venous route:
- Catecholamines: Noradrenaline, adrenaline (dose greater than 0.2µg/kg/min)
- Total parenteral nutrition
- Glucose solutions at a concentration >20
- Potassium at a concentration >0.1mEq/ml
- Vesicants
- Fluids with pH <5 or >9

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients admitted to the ICU for whom an indication for placement of a MidLine catheter is identified during their ICU stay

Sampling Method

Non-Probability Sample