Midline CatheterMVCNCT05835531
Evaluation of the Efficacy and Safety of Midline Venous Catheters
An observational study of Midline Catheter, run by Hospital El Cruce at 1 site in Argentina.
Trial summary
Central venous catheters are fundamental tools in medical practice, but their use carries frequent local and systemic complications, with bloodstream infection (bacteremia) and thrombus formation being the most frequent and serious. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Midline Catheter
- What is being tested?
- Catheters comparation
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteArgentina
- Study dates
- 20 Mar 2022to 30 Jun 2023
- How long will I take part?
- 1 Year
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with prolonged hospitalization in ICU (>10 days)
Who may be able to join
None listed.
Who cannot join
- Pregnant women and terminal patients.
- Skin infection at the site at the insertion site.
- Central vascular occlusions, including patients with pacemakers.
- Fistula for dialysis.
- Mastectomy and lymphedema.
- Positive blood cultures at the time of placement.
- Coagulation disorders.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital El Cruce
San Juan Bautista, Buenos Aires, 1888
Néstor Pistillo, MD, +5401142109000, néstor.pistillo@hospitalelcruce.org
About this study
Central venous catheters are fundamental tools in medical practice, but their use carries frequent local and systemic complications, with bloodstream infection (bacteremia) and thrombus formation being the most frequent and serious. Both complications prolong hospitalization time, increase morbidity, mortality, and hospital costs. Medium access peripheral venous catheters (MC) are a low-cost, easy-to-place, and highly-durable option that offers greater patient comfort and less pain, among other advantages. The objective of this study is to determine if the implementation of a team specialized in the placement of midline (CM) catheters reduces the incidence of infections associated with central venous catheters, decreases the cost of hospitalization, and preserves venous capital in patients admitted to ICU.
Read the detailed description
Central venous catheters are fundamental tools in medical practice, but their use carries frequent local and systemic complications, with bloodstream infection (bacteremia) and thrombus formation being the most frequent and serious. Both complications prolong hospitalization time, increase morbidity, mortality, and hospital costs. Promoting policies to prevent catheter-associated infections (CAIs) not only reduces the number of complications but is also essential to mitigate and control the development of multidrug-resistant organisms. The mechanism by which catheters become colonized is multifactorial and complex. Mainly, bacteria access the catheter through three access routes: 1) migration of superficial organisms that follow the path of the catheter until they colonize its tip. Generally, this extraluminal form of colonization causes bacteremia in the first days of catheterization. 2) The intraluminal route is the most frequent form of colonization. Inadequate cleaning of system connections, especially in multiple-lumen and multiple-path catheters, allows bacteria to enter after the first week of use. The third colonization route is rare and is due to hematogenous seeding of bacteria from a distant focus of infection or intrinsic contamination of the infused fluid. Other factors that also favor catheter colonization are the type of material (Teflon is less friendly to the vein), the number of lumens (directly proportional to the risk of infection), the nutritional and immunological deterioration of the individual, the type of infusion administered and the insertion site.
Medium access peripheral venous catheters (MC) are a low-cost, easy-to-place, and highly-durable option that offers greater patient comfort and less pain, among other advantages. They are placed using the Seldinger surgical technique at the foot of the bed, in a simple manner, and under ultrasound guidance. The catheter enters through a peripheral vein near the elbow crease and its tip is positioned at the level of the axillary vein, facilitating the infusion of drugs with an osmolarity <600 mOsm, pH range of 5 to 9, and blood derivatives. The success rate of the procedure is almost 100%, particularly if an expert performs the catheterization.
Midline catheters are an intermediate type of catheter between peripheral and central lines. This makes them a suitable choice for patients who are chronically hospitalized in intensive care units.
The benefits of midline catheters include a longer duration of use compared to peripheral catheters (up to 28 days), a lower incidence of procedure-related complications such as pneumothorax and infections and thrombosis compared to central lines. Moreover, they enable early removal of central lines and can be a viable option for patients with challenging vascular access, aiding in the preservation of venous reserve, which is often disregarded. These factors suggest that their use can result in decreased hospital costs. Unlike centrally inserted catheters, which require a physician's intervention for placement and removal, midline catheters can be inserted and removed by nursing professionals.
- Conditions
- Midline Catheter
- Being tested
- Catheters comparation
- Keywords
- infusion therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheters comparationDevice
Also called MIDLINE VENOUS CATHETERS
Assessment of incidence of complications associated with midline catheters
What is being measured
The primary outcome is the main question the study is designed to answer.
infection reduction
Assessment of incidence of complications associated with midline catheters
Measured: 1 year
Secondary outcomes (1)
thrombosis reduction
Assessment of incidence of complications associated with midline catheters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start20 Mar 2022
- Primary completion30 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Midline CatheterStudies of the same condition, open and under way.
- 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
- 400 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospital El Cruce
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nestor Pistillo, Hospital El Cruce
- Investigators
- Maximiliano Paz, BSN, Study director, Hospital El Cruce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835531
- Sponsor's protocol ID
- 026/2022
- Acronym
- MVC
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27397766Zheng WM. Some exact results and approximations for cluster growth on the Cayley tree. Phys Rev A Gen Phys. 1987 Dec 15;36(12):5851-5853. doi: 10.1103/physreva.36.5851. No abstract available.
PubMed 9898877Hadaway L, Mermel LA. Midline Catheters: Could They Replace a Central Vascular Access Device? J Infus Nurs. 2022 Jul-Aug 01;45(4):220-224. doi: 10.1097/NAN.0000000000000471.
PubMed 35820127Terrault NA, Zhou S, Combs C, Hahn JA, Lake JR, Roberts JP, Ascher NL, Wright TL. Prophylaxis in liver transplant recipients using a fixed dosing schedule of hepatitis B immunoglobulin. Hepatology. 1996 Dec;24(6):1327-33. doi: 10.1002/hep.510240601.
PubMed 8938155
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Midline Venous Catheters
- ClinicalTrials.gov ID
- NCT05835531
- Acronym / sponsor ID
- MVC / 026/2022
- Conditions
- Midline Catheter
- Keywords
- infusion therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hospital El CruceUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 28 Apr 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.
Central venous catheters are fundamental tools in medical practice, but their use carries frequent local and systemic complications, with bloodstream infection (bacteremia) and thrombus formation being the most frequent and serious. Both complications prolong hospitalization time, increase morbidity, mortality, and hospital costs. Medium access peripheral venous catheters (MC) are a low-cost, easy-to-place, and highly-durable option that offers greater patient comfort and less pain, among other advantages. The objective of this study is to determine if the implementation of a team specialized in the placement of midline (CM) catheters reduces the incidence of infections associated with central venous catheters, decreases the cost of hospitalization, and preserves venous capital in patients admitted to ICU.
Detailed description
Central venous catheters are fundamental tools in medical practice, but their use carries frequent local and systemic complications, with bloodstream infection (bacteremia) and thrombus formation being the most frequent and serious. Both complications prolong hospitalization time, increase morbidity, mortality, and hospital costs. Promoting policies to prevent catheter-associated infections (CAIs) not only reduces the number of complications but is also essential to mitigate and control the development of multidrug-resistant organisms. The mechanism by which catheters become colonized is multifactorial and complex. Mainly, bacteria access the catheter through three access routes: 1) migration of superficial organisms that follow the path of the catheter until they colonize its tip. Generally, this extraluminal form of colonization causes bacteremia in the first days of catheterization. 2) The intraluminal route is the most frequent form of colonization. Inadequate cleaning of system connections, especially in multiple-lumen and multiple-path catheters, allows bacteria to enter after the first week of use. The third colonization route is rare and is due to hematogenous seeding of bacteria from a distant focus of infection or intrinsic contamination of the infused fluid. Other factors that also favor catheter colonization are the type of material (Teflon is less friendly to the vein), the number of lumens (directly proportional to the risk of infection), the nutritional and immunological deterioration of the individual, the type of infusion administered and the insertion site.
Medium access peripheral venous catheters (MC) are a low-cost, easy-to-place, and highly-durable option that offers greater patient comfort and less pain, among other advantages. They are placed using the Seldinger surgical technique at the foot of the bed, in a simple manner, and under ultrasound guidance. The catheter enters through a peripheral vein near the elbow crease and its tip is positioned at the level of the axillary vein, facilitating the infusion of drugs with an osmolarity <600 mOsm, pH range of 5 to 9, and blood derivatives. The success rate of the procedure is almost 100%, particularly if an expert performs the catheterization.
Midline catheters are an intermediate type of catheter between peripheral and central lines. This makes them a suitable choice for patients who are chronically hospitalized in intensive care units.
The benefits of midline catheters include a longer duration of use compared to peripheral catheters (up to 28 days), a lower incidence of procedure-related complications such as pneumothorax and infections and thrombosis compared to central lines. Moreover, they enable early removal of central lines and can be a viable option for patients with challenging vascular access, aiding in the preservation of venous reserve, which is often disregarded. These factors suggest that their use can result in decreased hospital costs. Unlike centrally inserted catheters, which require a physician's intervention for placement and removal, midline catheters can be inserted and removed by nursing professionals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prolonged hospitalization in ICU (>10 days)
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Pregnant women and terminal patients.
- Skin infection at the site at the insertion site.
- Central vascular occlusions, including patients with pacemakers.
- Fistula for dialysis.
- Mastectomy and lymphedema.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheters comparationAlso: MIDLINE VENOUS CATHETERSAssessment of incidence of complications associated with midline catheters | Device | – |
Primary outcome
infection reduction
Time frame: 1 year
Assessment of incidence of complications associated with midline catheters
1 secondary outcome
thrombosis reduction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 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 9898877Zheng WM. Some exact results and approximations for cluster growth on the Cayley tree. Phys Rev A Gen Phys. 1987 Dec 15;36(12):5851-5853. doi: 10.1103/physreva.36.5851. No abstract available.
- Background: PubMed 35820127Hadaway L, Mermel LA. Midline Catheters: Could They Replace a Central Vascular Access Device? J Infus Nurs. 2022 Jul-Aug 01;45(4):220-224. doi: 10.1097/NAN.0000000000000471.
- Background: PubMed 8938155Terrault NA, Zhou S, Combs C, Hahn JA, Lake JR, Roberts JP, Ascher NL, Wright TL. Prophylaxis in liver transplant recipients using a fixed dosing schedule of hepatitis B immunoglobulin. Hepatology. 1996 Dec;24(6):1327-33. doi: 10.1002/hep.510240601.
- Individual participant dataSharing planned: No
Related trials for Midline Catheter
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
Not yet recruitingObservational study
An Observational, Multinational, In Hospital Evaluation of Catheter Utilization Rates in Female Patients Using Indwelling Urinary Catheters and the PureWick™ Flex Female External Catheter Across Europe and the Middle East
Urinary Incontinence, Limited Mobility
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
RecruitingObservational study
Outpatient Midline Catheter in Patients Receiveing Lidocaine Infusion Series.
Midline Catheter, Lidocaine Infusion
Active, not recruiting
Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablation for Atrial Fibrillation
Atrial Fibrillation
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.
Maximiliano Paz, BSN study director
Hospital El Cruce
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 Midline Catheter, run by Hospital El Cruce at 1 site in Argentina.
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 0 inclusion and 7 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 28 Apr 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 Argentina. 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 Nestor Pistillo, MD (42109000 ext. 3507, nestor.pistillo@hospitalelcruce.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection reduction (time frame: 1 year). 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 NCT05835531, which also lists 4 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 28 Apr 2023.