Catheter ComplicationsNCT05710835
Application Study of Infusing Irritant Medications Through Midline Catheter Based on Real World Study
An observational study of Catheter Complications, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about the effect on midline catheter outcomes when infusing irritant medications through midline catheter. The main questions it aims to answer are:Identify the current situation of infusing irritant medications through midline catheter;Explore the effect on midline… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Catheter Complications
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 30 Jun 2024
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients at a 3A hospital
Who may be able to join
- Age ≥14 years old
- Patients who had a midline catheter
Who cannot join
- Patients who received vesicant medications through the midline catheter
- Patients who had both a midline catheter and a central vascular access device
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Linfang Zhao
Hangzhou, Zhejiang, 310000
Linfang Zhao, 13588819123, 3193159@zju.edu.cn
Xiuzhu Cao, 13588477316, Caoxz@srrsh.com
About this study
The goal of this observational study is to learn about the effect on midline catheter outcomes when infusing irritant medications through midline catheter. The main questions it aims to answer are:Identify the current situation of infusing irritant medications through midline catheter;Explore the effect on midline catheter outcomes when infusing irritant medications through midline catheter;Identify specific medications that affect catheter outcomes.
Read the detailed description
First, the patients were divided into two groups according to whether irritant medications were infused or not,then observed the rate of complications between the two groups.Second, grouped according to the irritant medications, Identify specific medications that affect catheter outcomes through statistical analysis.
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Dec 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)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
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Linfang, Sir Run Run Shaw Hospital
- Investigators
- Linfang Zhao, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710835
- Sponsor's protocol ID
- IVTEAM202301
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams DZ, Little A, Vinsant C, Khandelwal S. The Midline Catheter: A Clinical Review. J Emerg Med. 2016 Sep;51(3):252-8. doi: 10.1016/j.jemermed.2016.05.029. Epub 2016 Jul 5.
PubMed 27397766Qin KR, Pittiruti M, Nataraja RM, Pacilli M. Long peripheral catheters and midline catheters: Insights from a survey of vascular access specialists. J Vasc Access. 2021 Nov;22(6):905-910. doi: 10.1177/1129729820966226. Epub 2020 Oct 20.
PubMed 33078685Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, Meyer BM, Nickel B, Rowley S, Sharpe E, Alexander M. Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1):S1-S224. doi: 10.1097/NAN.0000000000000396. No abstract available.
PubMed 33394637Prasanna N, Yamane D, Haridasa N, Davison D, Sparks A, Hawkins K. Safety and efficacy of vasopressor administration through midline catheters. J Crit Care. 2021 Feb;61:1-4. doi: 10.1016/j.jcrc.2020.09.024. Epub 2020 Oct 2.
PubMed 33049486Anderson J,Greenwell A,Louderback J,et al.Comparison of Outcomes of Extended Dwell/Midline Peripheral Intravenous Catheters and Peripherally Inserted Central Catheters in Children[J].Journal of Vascular Access,2016,21(3): 158-164.
Knottnerus JA, Tugwell P. Real world research. J Clin Epidemiol. 2010 Oct;63(10):1051-2. doi: 10.1016/j.jclinepi.2010.08.001. No abstract available.
PubMed 20728043Mermel LA, Parenteau S, Tow SM. The risk of midline catheterization in hospitalized patients. A prospective study. Ann Intern Med. 1995 Dec 1;123(11):841-4. doi: 10.7326/0003-4819-123-11-199512010-00005.
PubMed 7486466Hallam C, Weston V, Denton A, Hill S, Bodenham A, Dunn H, Jackson T. Development of the UK Vessel Health and Preservation (VHP) framework: a multi-organisational collaborative. J Infect Prev. 2016 Mar;17(2):65-72. doi: 10.1177/1757177415624752. Epub 2016 Jan 10.
PubMed 28989456Alexandrou E,Ramjan LM,Spencer T,et al.The use of midline catheters in the adult acute care setting-clinical implications and recommendations for practice[J]. Journal of the Association for Vascular Access,2011,16(1): 35-41.
Marsh N, Webster J, Larson E, Cooke M, Mihala G, Rickard CM. Observational Study of Peripheral Intravenous Catheter Outcomes in Adult Hospitalized Patients: A Multivariable Analysis of Peripheral Intravenous Catheter Failure. J Hosp Med. 2018 Feb 1;13(2):83-89. doi: 10.12788/jhm.2867. Epub 2017 Oct 18.
PubMed 29073316Anderson NR. Midline catheters: the middle ground of intravenous therapy administration. J Infus Nurs. 2004 Sep-Oct;27(5):313-21. doi: 10.1097/00129804-200409000-00005.
PubMed 15385895O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
PubMed 21511081Mushtaq A, Navalkele B, Kaur M, Krishna A, Saleem A, Rana N, Gera S, Chandramohan S, Surapaneni M, Chopra T. Comparison of complications in midlines versus central venous catheters: Are midlines safer than central venous lines? Am J Infect Control. 2018 Jul;46(7):788-792. doi: 10.1016/j.ajic.2018.01.006. Epub 2018 Mar 7.
PubMed 29525366DeVries M, Lee J, Hoffman L. Infection free midline catheter implementation at a community hospital (2 years). Am J Infect Control. 2019 Sep;47(9):1118-1121. doi: 10.1016/j.ajic.2019.03.001. Epub 2019 Apr 30.
PubMed 31047692Sharp R, Esterman A, McCutcheon H, Hearse N, Cummings M. The safety and efficacy of midlines compared to peripherally inserted central catheters for adult cystic fibrosis patients: a retrospective, observational study. Int J Nurs Stud. 2014 May;51(5):694-702. doi: 10.1016/j.ijnurstu.2013.09.002. Epub 2013 Sep 14.
PubMed 24103730
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Study of Infusing Irritant Medications Through Midline Catheter Based on Real World Study
- ClinicalTrials.gov ID
- NCT05710835
- Acronym / sponsor ID
- IVTEAM202301
- Conditions
- Catheter Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 2 Feb 2023 (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.
The goal of this observational study is to learn about the effect on midline catheter outcomes when infusing irritant medications through midline catheter. The main questions it aims to answer are:Identify the current situation of infusing irritant medications through midline catheter;Explore the effect on midline catheter outcomes when infusing irritant medications through midline catheter;Identify specific medications that affect catheter outcomes.
Detailed description
First, the patients were divided into two groups according to whether irritant medications were infused or not,then observed the rate of complications between the two groups.Second, grouped according to the irritant medications, Identify specific medications that affect catheter outcomes through statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- 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
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at a 3A hospital
Key inclusion criteria (2 listed)
- Age ≥14 years old
- Patients who had a midline catheter
Key exclusion criteria (2 listed)
- Patients who received vesicant medications through the midline catheter
- Patients who had both a midline catheter and a central vascular access device
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
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 2 Feb 2023.
- Background: PubMed 27397766Adams DZ, Little A, Vinsant C, Khandelwal S. The Midline Catheter: A Clinical Review. J Emerg Med. 2016 Sep;51(3):252-8. doi: 10.1016/j.jemermed.2016.05.029. Epub 2016 Jul 5.
- Background: PubMed 33078685Qin KR, Pittiruti M, Nataraja RM, Pacilli M. Long peripheral catheters and midline catheters: Insights from a survey of vascular access specialists. J Vasc Access. 2021 Nov;22(6):905-910. doi: 10.1177/1129729820966226. Epub 2020 Oct 20.
- Background: PubMed 33394637Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, Meyer BM, Nickel B, Rowley S, Sharpe E, Alexander M. Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1):S1-S224. doi: 10.1097/NAN.0000000000000396. No abstract available.
- Background: PubMed 33049486Prasanna N, Yamane D, Haridasa N, Davison D, Sparks A, Hawkins K. Safety and efficacy of vasopressor administration through midline catheters. J Crit Care. 2021 Feb;61:1-4. doi: 10.1016/j.jcrc.2020.09.024. Epub 2020 Oct 2.
- BackgroundAnderson J,Greenwell A,Louderback J,et al.Comparison of Outcomes of Extended Dwell/Midline Peripheral Intravenous Catheters and Peripherally Inserted Central Catheters in Children[J].Journal of Vascular Access,2016,21(3): 158-164.
- Background: PubMed 20728043Knottnerus JA, Tugwell P. Real world research. J Clin Epidemiol. 2010 Oct;63(10):1051-2. doi: 10.1016/j.jclinepi.2010.08.001. No abstract available.
- Background: PubMed 7486466Mermel LA, Parenteau S, Tow SM. The risk of midline catheterization in hospitalized patients. A prospective study. Ann Intern Med. 1995 Dec 1;123(11):841-4. doi: 10.7326/0003-4819-123-11-199512010-00005.
- Background: PubMed 28989456Hallam C, Weston V, Denton A, Hill S, Bodenham A, Dunn H, Jackson T. Development of the UK Vessel Health and Preservation (VHP) framework: a multi-organisational collaborative. J Infect Prev. 2016 Mar;17(2):65-72. doi: 10.1177/1757177415624752. Epub 2016 Jan 10.
- BackgroundAlexandrou E,Ramjan LM,Spencer T,et al.The use of midline catheters in the adult acute care setting-clinical implications and recommendations for practice[J]. Journal of the Association for Vascular Access,2011,16(1): 35-41.
- Background: PubMed 29073316Marsh N, Webster J, Larson E, Cooke M, Mihala G, Rickard CM. Observational Study of Peripheral Intravenous Catheter Outcomes in Adult Hospitalized Patients: A Multivariable Analysis of Peripheral Intravenous Catheter Failure. J Hosp Med. 2018 Feb 1;13(2):83-89. doi: 10.12788/jhm.2867. Epub 2017 Oct 18.
- Background: PubMed 15385895Anderson NR. Midline catheters: the middle ground of intravenous therapy administration. J Infus Nurs. 2004 Sep-Oct;27(5):313-21. doi: 10.1097/00129804-200409000-00005.
- Background: PubMed 21511081O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
- 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.
Linfang Zhao 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 2 Feb 2023. 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 Linfang Zhao (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). 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 NCT05710835, which also lists 21 linked publications.
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 2 Feb 2023.