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OpenTrials
Completed

NCT Number: NCT05412108

Prospective Evaluation of Complications of MidLine Catheters in the ICU

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Du Mans

Le Mans, 72000, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Acronym: COMIDREA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2022
Registry last updated
Jul 1, 2026

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.

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