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

NCT06454552 | Not Yet Recruiting

• 1 other identifier: 2024-2082-01
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catheter Complications

Outcome Measures

Primary Outcomes (1)

• catheter complications

  catheter complications rate

  during catheter indwelling procedure

Study Arms (2)

irritant medications group

Patients who used midline catheter to infuse irritant medications.

nonirritant medications group

Patients who used midline catheter to infuse nonirritant medications.

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, 310016, China

Location

Related Publications (1)

• Zhao L, Cao X, Liu C, Wang J, Jin X, Zeng X, Li X, Zhuang Y. Impact of irritating infusates via midline catheters on vascular complications: a multicentre prospective cohort study protocol in China. BMJ Open. 2025 Aug 31;15(8):e093180. doi: 10.1136/bmjopen-2024-093180.

  PMID: 40887123 DERIVED

Study Officials

• Zhao Linfang

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Linfang

CONTACT

13588819123; 3193159@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: June 11, 2024
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)