A Study of Stimulant Medications Infusion Through Midline Catheters Based on Real-world Data

Based on the previous research, this study intends to explore the outcome of trans-MC infusion of stimulant drugs when the MC tip is located in the subclavian vein/chest wall segment axillary vein, especially to analyze the relationship between drug dose, infusion days and catheter-related complications, so as to provide a basis for the clinical application of MC infusion stimulant drugs, provide evidence for the revision of infusion practice guidelines, and ensure the safety of patients' infusion. Reduce the occurrence of adverse events, provide a basis for further expanding the clinical application scope of MC, reduce unnecessary peripherally inserted central venous catheters (PICC) and central venous catheters (CVC) and other central venous catheters, and reduce medical costs.

Study Overview

• Status: Not yet recruiting
• Conditions: Catheter Complications

Detailed Description

Midline catheters were inserted by hospital nurses in each center, and patients with MC catheters were included in order, and baseline data of patients were extracted from medical records, including patients' age, gender, education level, body mass index, occupation, admission diagnosis, thrombosis history, major surgery trauma history, chronic medical history, catheterization history and related examination indicators. At the same time, researchers authorized by the principal investigators of each center and uniformly trained researchers will collect data and record the puncture situation during catheterization: including catheter, puncture method, puncture location, puncture arm, puncture site, punctured blood vessel and vascular diameter, number of puncture needles, catheter brand, catheter model, catheter insertion length, catheter exposed length, catheter tip position; During the catheter indwelling period, the catheter function and complications were collected until extubation, and the reasons for extubation, transcatheter blood collection, and vascular intima were recorded, and the patient's transcatheter drug information was extracted from the medical record.

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Zhao Linfang; Phone Number: 13588819123; Email: 3193159@zju.edu.cn

Study Locations

• China
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study intends to prospectively include patients who have been admitted to multiple centers such as Sir Run Run Shaw Hospital (team leader unit) affiliated to Zhejiang University School of Medicine and have MC implanted.

Description

Inclusion Criteria:

• Age greater than or equal to 18 years old.
• In patients with conventional indwelling single-chamber three-way valve MC, the catheter tip is located in the axillary vein or subclavian vein of the chest wall segment.

Exclusion Criteria:

• Those who have been placed with a central venous catheter during MC insertion.
• Vulnerable groups, including people with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiterates, etc.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
irritant medications group; Patients who used midline catheter to infuse irritant medications.
nonirritant medications group; Patients who used midline catheter to infuse nonirritant medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
catheter complications	catheter complications rate	during catheter indwelling procedure

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital
• Investigators: Principal Investigator: Zhao Linfang, Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 11, 2024
• Primary Completion (Estimated): February 14, 2025
• Study Completion (Estimated): February 14, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-2082-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No