Prospective Evaluation of Complications of MidLine Catheters in the ICU

NCT05412108 | Unknown

• 1 other identifier: CHM-2020/S03/13
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter Complications

Keywords

Midline catheter; ICU Hospitalization

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• ICU Hospitalization
• Indication for MidLine catheter placement during the stay

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (1)

Centre Hospitalier Du Mans

Le Mans, 72000, France

RECRUITING

Central Study Contacts

Christelle JADEAU

CONTACT

+33244710781; cjadeau@ch-lemans.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 9, 2022
• Study Start: January 20, 2022
• Primary Completion: January 20, 2025
• Study Completion: March 1, 2025
• Last Updated: June 9, 2022

Record last verified: 2022-05

Locations

FR (1)