Catheter ComplicationsNCT06454552
A Study of Stimulant Medications Infusion Through Midline Catheters Based on Real-world Data
An observational study of Catheter Complications, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Complications
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2024to 14 Feb 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, 310016
About this study
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.
Read the 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.
- Conditions
- Catheter Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
catheter complications
catheter complications rate
Measured: during catheter indwelling procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start11 Jun 2024 (estimated)
- Primary completion14 Feb 2025 (estimated)
- Study completion14 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheter ComplicationsStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhao Linfang, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454552
- Sponsor's protocol ID
- 2024-2082-01
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40887123
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Stimulant Medications Infusion Through Midline Catheters Based on Real-world Data
- ClinicalTrials.gov ID
- NCT06454552
- Acronym / sponsor ID
- 2024-2082-01
- Conditions
- Catheter Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 11 Jun 2024 (estimated)
- Primary completion
- 14 Feb 2025 (estimated)
- Study completion
- 14 Feb 2025 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| irritant medications group | – | –Patients who used midline catheter to infuse irritant medications. |
| nonirritant medications group | – | –Patients who used midline catheter to infuse nonirritant medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
catheter complications
Time frame: during catheter indwelling procedure
catheter complications rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Derived from this study: PubMed 40887123Zhao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhao Linfang principal investigator
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter Complications, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhao Linfang (13588819123, 3193159@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
catheter complications (time frame: during catheter indwelling procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06454552, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.