Prospective Evaluation of Complications of MidLine Catheters in the ICU (COMIDREA)

June 7, 2022 updated by: Centre Hospitalier le Mans

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Mans, France, 72000
        • Recruiting
        • Centre Hospitalier du Mans
        • Principal Investigator:
          • Cédric DARREAU, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the incidence of severe complications associated with the use of CMs in ICUs
Time Frame: From midline catheter placement to hospital discharge (up to 28 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier le Mans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Anticipated)

January 20, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

June 7, 2022

First Posted (Actual)

June 9, 2022

Study Record Updates

Last Update Posted (Actual)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHM-2020/S03/13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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