PIcc Cost EffectiveneSS and Safety of Infusional Therapy

NCT03392831 | Unknown

• 1 other identifier: 170529
• Study Type: interventional
• Target: 624
• Locations: 0 countries
• Sites: N/A

Brief 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. 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).

Conditions

Thrombosis; Infection

Keywords

Central Venous Catheters; Vascular Access Devices; Nursing; Cost Effectiveness; PICC

Outcome Measures

Primary Outcomes (4)

• infectious complications

  bloodstream infection

  up to 30 days or the end of therapy

• thrombotic complications

  radiographically-confirmed upper-extremity deep vein thrombosis

  up to 30 days or the end of therapy

• mechanical complications

  chest X-ray

  up to 30 days or the end of therapy

• accidental removal

  obstruction or accidental removal

  up to 30 days or need for another catheter

Secondary Outcomes (1)

• Cost Effectiveness

  up to 30 days or the end of therapy

Study Arms (2)

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.

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.

Other: Central venous catheter

Interventions

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

Peripherally inserted central catheter

Central venous catheter OTHER

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.

Central venous catheter

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

MeSH Terms

Conditions

Thrombosis; Infections

Interventions

Catheterization, Peripheral; Central Venous Catheters

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Vascular Access Devices; Catheters; Equipment and Supplies

Study Officials

• Carisi A Polanczyk

  Federal University of Rio Grande do Sul - Faculty of Medicine

  STUDY DIRECTOR

• Marco A Lumertz Saffi

  Hospital de Clinicas de Porto Alegre

  STUDY DIRECTOR

• Jeruza L Neyeloff

  Hospital de Clinicas de Porto Alegre

  STUDY DIRECTOR

Central Study Contacts

Eneida R Rabelo da Silva

CONTACT

+5551 33085226; eneidarabelo@gmail.com

Simone S Fantin

CONTACT

+555133598017; sfantin@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Randomized Open Blinded End-Point (PROBE) study

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 8, 2018
• Study Start: April 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: January 8, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share