PIcc Cost EffectiveneSS and Safety of Infusional Therapy

NCT03392831 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 624

Last updated 2018-01-08

No results posted yet for this study

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

Interventions

OTHER

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

Central venous catheter

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.

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Carisi A Polanczyk · Federal University of Rio Grande do Sul - Faculty of Medicine

  • Marco A Lumertz Saffi · Hospital de Clinicas de Porto Alegre

  • Jeruza L Neyeloff · Hospital de Clinicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2019-12-31
Completion
2021-12-31

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03392831 on ClinicalTrials.gov