Prospective Evaluation of Complications of MidLine Catheters in the ICU

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05412108

Acronym

COMIDREA

Enrollment

148

Registered

2022-06-09

Start date

2022-02-17

Completion date

2024-12-31

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Complications

Keywords

Midline catheter, ICU Hospitalization

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Describe the incidence of severe complications associated with the use of CMs in ICUs	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

Countries

France

Outcome results