ThrombosisPrInCESSNCT03392831
PIcc Cost EffectiveneSS and Safety of Infusional Therapy
A study testing Peripherally inserted central catheter (PICC) and Central venous catheter in people with Thrombosis and Infection, run by Hospital de Clinicas de Porto Alegre.
Trial summary
Infusion therapy comprises the parenteral administration of solutions, through peripheral or central vascular access. Some solutions and drugs are highly irritating to the vascular endothelium and therefore cannot be administered in peripheral vessels, because increase the risk of phlebitis and/or tissue necrosis. Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Thrombosis, Infection
- What is being tested?
- Peripherally inserted central catheter (PICC) and Central venous catheter
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 624 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Dec 2021
- Phase
- Interventional
- 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 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient above 5 years old,
- Hospitalized,
- With prescription of infusion therapy for 10 days or more of antibiotics, antineoplastics or other drugs with a pH lower than 5 or higher than 9 and / or osmolarity above 900 mOsm / l, parenteral nutrition or hypertonic solutions.
Who cannot join
- Insertion of the central catheter in emergency situations.
- Critical patient in the acute or terminal stage;
- Chronic renal disease stage IV or V and indication of hemodialysis;
- Pediatric patients with leukemia until the induction phase;
- Adult patients diagnosed with acute myeloid leukemia;
- Autologous and allogenic marrow transplantation;
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- Upper limb with anatomical alteration, presence of arteriovenous fistula, axillary emptying or previous vascular procedure;
- Presence of skin changes in the area of the puncture, such as thrombophlebitis, dermatitis, cellulitis, burn among others;
- Patient using crutches or devices that require exertion or support in the upper limbs.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Cost-Effectiveness and Safety of Infusional Therapy With Central Venous Catheters Versus Peripherally Inserted Central Catheters: a Randomized Clinical Trial
Infusion therapy comprises the parenteral administration of solutions, through peripheral or central vascular access. Some solutions and drugs are highly irritating to the vascular endothelium and therefore cannot be administered in peripheral vessels, because increase the risk of phlebitis and/or tissue necrosis. Thus, the alternative is the central venous catheter (CVC) where the access can be by direct puncture of a central vessel or peripheral vessel puncture with progression of the catheter until central positioning, through a peripherally inserted central catheter (PICC).
We must take into account that indication, insertion, handling and maintenance must be balanced with risks, benefits and costs. The insertion and maintenance of both catheters are not free of complications. Among the most frequent are: Infection, thrombosis, lumen occlusion and accidental early removal of the catheter. This often implies in the need for new vascular access, impacting on morbidity and increased treatment costs.
Read more
The PICC has some advantages over CVC, for example: avoids repetitive punctures and consequently decreased handling/pain; a lower risk of infection; avoids the use of venous dissections; reduces the risks of pneumothorax/hemothorax; reduces the risk of infiltration, extravasation, necrosis tissue and chemical phlebitis. Further, the PICC can be used as a long-term catheter with easy handling in extra-hospital condition. All these advantages suggest that this technology offers lower cost to the health system and more benefits for patients. However, PICC is not available for use in infusion therapy in patients of the Brazilian public health system, except for neonates.
The available literature does not address cost-effectiveness studies of this technology in the international scope comparing the PICC versus CVC. And, similarly, we do not have studies conducted in Brazil to incorporate this technology into our public health system, based on its benefits and potential cost reduction.
In order to fill this gap, this study aims to test if the use of PICC in patients with infusional therapy equal or superior to 10 days (Intervention Group), will show a lower incidence in the outcomes (infection, thrombosis or mechanical complications), besides being more cost-effective when compared to the use of CVC of short stay (Control Group).
Read the detailed description
Patient recruitment: Adult and pediatric patients will be included during hospitalization in the clinical/surgical units at the Hospital de Clínicas de Porto Alegre.
Variables of registry: Clinical data (diagnosis, reason for indication of catheter, site of insertion, vessel size, pharmacological treatment); Socio-demographic (age, sex, education, income); Ultrasonography (vessel evaluation); Radiography (to ensure the correct positioning of the catheter); economic variables (costs of all inputs used).
Data collection: All variables will be recorded in an instrument developed by the authors.
Statistical analysis: Continuous variables will be described using means and standard deviations or median and range in case of asymmetric distribution of data. Categorical variables will be presented using frequency distribution. Analyses will be conducted using chi-square and t tests for independent samples. P values <0.05 will be considered statistically significant. A Statistical Package for Social Sciences v.20.0 will be used. The Cox Regression Analysis and Log-rank test will compare the groups in relation to complication-free survival.
Cost-effectiveness analysis: The cost-effectiveness analysis will be measured by the incremental cost-effectiveness ratio (ICER), showed by the difference in cost between intervention and control group, divided by the difference in their effect. It represents the average incremental cost associated with 1 additional unit of the measure of effect. The cost-effectiveness analysis will be based on the cost estimate for insertion and maintenance of the catheter, including values of the inputs used, medicines, costs with professionals, surgical environment, laboratory and imaging exams.
- Conditions
- Thrombosis, Infection
- Being tested
- Peripherally inserted central catheter (PICC), Central venous catheter
- Keywords
- Central Venous Catheters, Vascular Access Devices, Nursing, Cost Effectiveness, PICC
- Medical subject headings
- Thrombosis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripherally inserted central catheter (PICC)Other
The peripherally inserted central catheter with different sizes (French scale). Trained vascular access nurses will perform the insertion of the PICC, guided by ultrasound at bedside using the Seldinger technique. A suitable sterile field will be established. In the case of children the procedure may be performed at the Ambulatory Surgical Center
Central venous catheterOther
The central venous catheter with different sizes (French scale). Trained doctors will perform the insertion of the CVC, guided by ultrasound at bedside using the Seldinger technique. A suitable sterile field will be established.The decision of the caliber depends on the clinical evaluation and need for multiple infusional therapy.
| Study group | Role | What they receive |
|---|---|---|
| Peripherally inserted central catheter | Experimental | The peripherally inserted central catheter (PICC) with 3 to 6 French calibers, with one, two or three lumens Groshong and PowerPICC models. These calibers are dependent on the amount of lumens, which are used for single or concomitant infusions. Receives: Other: Peripherally inserted central catheter (PICC) |
| Central venous catheter | Active comparator | The central venous catheter (CVC), with a short stay of 3 to 7 French gauges with one or more lumens. Receives: Other: Central venous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
infectious complications
bloodstream infection
Measured: up to 30 days or the end of therapy
thrombotic complications
radiographically-confirmed upper-extremity deep vein thrombosis
Measured: up to 30 days or the end of therapy
mechanical complications
chest X-ray
Measured: up to 30 days or the end of therapy
accidental removal
obstruction or accidental removal
Measured: up to 30 days or need for another catheter
Secondary outcomes (1)
Cost Effectiveness
reduction of the rates composite outcome of complications
- Catheter occlusion: significant reduction of infusion flow or an impairment of blood back-flow;
- Catheter damage, malposition and catheter migration.
Measured: up to 30 days or the end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study startApr 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Open Blinded End-Point (PROBE) study
- Masking
- None (open label)
- Enrolment
- 624 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carisi A Polanczyk, Study director, Federal University of Rio Grande do Sul - Faculty of MedicineMarco A Lumertz Saffi, Study director, Hospital de Clinicas de Porto AlegreJeruza L Neyeloff, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392831
- Sponsor's protocol ID
- 170529
- Acronym
- PrInCESS
- Status last verified
- Jan 2018
- First submitted
- 2 Jan 2018
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Cost-Effectiveness and Safety of Infusional Therapy With Central Venous Catheters Versus Peripherally Inserted Central Catheters: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03392831
- Acronym / sponsor ID
- PrInCESS / 170529
- Conditions
- Thrombosis, Infection
- Keywords
- Central Venous Catheters, Vascular Access Devices, Nursing, Cost Effectiveness, PICC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Jan 2018 (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.
Infusion therapy comprises the parenteral administration of solutions, through peripheral or central vascular access. Some solutions and drugs are highly irritating to the vascular endothelium and therefore cannot be administered in peripheral vessels, because increase the risk of phlebitis and/or tissue necrosis. Thus, the alternative is the central venous catheter (CVC) where the access can be by direct puncture of a central vessel or peripheral vessel puncture with progression of the catheter until central positioning, through a peripherally inserted central catheter (PICC).
We must take into account that indication, insertion, handling and maintenance must be balanced with risks, benefits and costs. The insertion and maintenance of both catheters are not free of complications. Among the most frequent are: Infection, thrombosis, lumen occlusion and accidental early removal of the catheter. This often implies in the need for new vascular access, impacting on morbidity and increased treatment costs.
The PICC has some advantages over CVC, for example: avoids repetitive punctures and consequently decreased handling/pain; a lower risk of infection; avoids the use of venous dissections; reduces the risks of pneumothorax/hemothorax; reduces the risk of infiltration, extravasation, necrosis tissue and chemical phlebitis. Further, the PICC can be used as a long-term catheter with easy handling in extra-hospital condition. All these advantages suggest that this technology offers lower cost to the health system and more benefits for patients. However, PICC is not available for use in infusion therapy in patients of the Brazilian public health system, except for neonates.
The available literature does not address cost-effectiveness studies of this technology in the international scope comparing the PICC versus CVC. And, similarly, we do not have studies conducted in Brazil to incorporate this technology into our public health system, based on its benefits and potential cost reduction.
In order to fill this gap, this study aims to test if the use of PICC in patients with infusional therapy equal or superior to 10 days (Intervention Group), will show a lower incidence in the outcomes (infection, thrombosis or mechanical complications), besides being more cost-effective when compared to the use of CVC of short stay (Control Group).
Detailed description
Patient recruitment: Adult and pediatric patients will be included during hospitalization in the clinical/surgical units at the Hospital de Clínicas de Porto Alegre.
Variables of registry: Clinical data (diagnosis, reason for indication of catheter, site of insertion, vessel size, pharmacological treatment); Socio-demographic (age, sex, education, income); Ultrasonography (vessel evaluation); Radiography (to ensure the correct positioning of the catheter); economic variables (costs of all inputs used).
Data collection: All variables will be recorded in an instrument developed by the authors.
Statistical analysis: Continuous variables will be described using means and standard deviations or median and range in case of asymmetric distribution of data. Categorical variables will be presented using frequency distribution. Analyses will be conducted using chi-square and t tests for independent samples. P values <0.05 will be considered statistically significant. A Statistical Package for Social Sciences v.20.0 will be used. The Cox Regression Analysis and Log-rank test will compare the groups in relation to complication-free survival.
Cost-effectiveness analysis: The cost-effectiveness analysis will be measured by the incremental cost-effectiveness ratio (ICER), showed by the difference in cost between intervention and control group, divided by the difference in their effect. It represents the average incremental cost associated with 1 additional unit of the measure of effect. The cost-effectiveness analysis will be based on the cost estimate for insertion and maintenance of the catheter, including values of the inputs used, medicines, costs with professionals, surgical environment, laboratory and imaging exams.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized Open Blinded End-Point (PROBE) study
| Arm | Type | Receives |
|---|---|---|
| Peripherally inserted central catheter | Experimental | Other: Peripherally inserted central catheter (PICC)The peripherally inserted central catheter (PICC) with 3 to 6 French calibers, with one, two or three lumens Groshong and PowerPICC models. These calibers are dependent on the amount of lumens, which are used for single or concomitant infusions. |
| Central venous catheter | Active comparator | Other: Central venous catheterThe central venous catheter (CVC), with a short stay of 3 to 7 French gauges with one or more lumens. |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient above 5 years old,
- Hospitalized,
- With prescription of infusion therapy for 10 days or more of antibiotics, antineoplastics or other drugs with a pH lower than 5 or higher than 9 and / or osmolarity above 900 mOsm / l, parenteral nutrition or hypertonic solutions.
Key exclusion criteria (9 listed)
- Insertion of the central catheter in emergency situations.
- Critical patient in the acute or terminal stage;
- Chronic renal disease stage IV or V and indication of hemodialysis;
- Pediatric patients with leukemia until the induction phase;
- Adult patients diagnosed with acute myeloid leukemia;
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 |
|---|---|---|
| Peripherally inserted central catheter (PICC)The peripherally inserted central catheter with different sizes (French scale). Trained vascular access nurses will perform the insertion of the PICC, guided by ultrasound at bedside using the Seldinger technique. A suitable sterile field will be established. In the case of children the procedure may be performed at the Ambulatory Surgical Center | Other | Peripherally inserted central catheter |
| Central venous catheterThe central venous catheter with different sizes (French scale). Trained doctors will perform the insertion of the CVC, guided by ultrasound at bedside using the Seldinger technique. A suitable sterile field will be established.The decision of the caliber depends on the clinical evaluation and need for multiple infusional therapy. | Other | Central venous catheter |
Primary outcome
infectious complications
Time frame: up to 30 days or the end of therapy
bloodstream infection
thrombotic complications
Time frame: up to 30 days or the end of therapy
radiographically-confirmed upper-extremity deep vein thrombosis
mechanical complications
Time frame: up to 30 days or the end of therapy
chest X-ray
accidental removal
Time frame: up to 30 days or need for another catheter
obstruction or accidental removal
1 secondary outcome
Cost Effectiveness
Time frame: up to 30 days or the end of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- 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.
Carisi A Polanczyk study director
Federal University of Rio Grande do Sul - Faculty of Medicine
Marco A Lumertz Saffi study director
Hospital de Clinicas de Porto Alegre
Jeruza L Neyeloff study director
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Peripherally inserted central catheter (PICC) and Central venous catheter in people with Thrombosis and Infection, run by Hospital de Clinicas de Porto Alegre.
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 3 inclusion and 9 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 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Eneida R Rabelo da Silva (+5551 33085226, eneidarabelo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infectious complications (time frame: up to 30 days or the end of therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2018.