Prospective Evaluation of Complications of MidLine Catheters in the ICU

Catheter Complications Clinical Trial

— COMIDREA  

Official title:

Prospective Evaluation of Complications of MidLine Catheters in the ICU

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05412108
• Other study ID #: CHM-2020/S03/13
• Status: Recruiting
• Start date: January 20, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2022
• Source: Centre Hospitalier le Mans
• Contact: Christelle JADEAU
• Phone: +33244710781
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2025
• Est. primary completion date: January 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter Complications

Locations

Country	Name	City	State
France	Centre Hospitalier Du Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)