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Safety and Bacteraemia Between Peripherally Inserted and Central Inserted Catheters.

Randomized, Prospective, Single-center Study to Compare the Effectiveness and Safety in Terms of Catheter Bacteraemia, Between Peripherally Inserted Central Catheters and Non-tunneled Central Venous Catheter in Tertiary Hospital

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02538159
Acronym
PYCBAC
Enrollment
247
Registered
2015-09-02
Start date
2015-09-02
Completion date
2017-07-11
Last updated
2018-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Related Infections

Keywords

Non-tunneled Central venous catheter, Bacteraemia, Peripherally inserted central venous catheter

Brief summary

Clinical, prospective, single-center, national trial. open and randomized at 1: 1 to compare the rate of bacteremia associated between non-tunneled Central venous catheter and peripheral inserted central catheter.

Interventions

DEVICECVC

The inclusion of any CVC is an aseptic technique, so hand washing, mask, cap is required, sterile gloves and scoping insertion using sterile drapes. The skin disinfection is carried out with 2% chlorhexidine alcohol 17, to be dried completely before insertion of the catheter (30 seconds). No prophylactic antibiotic was administered before insertion. In the case of CVC, the subclavian vein of choice will be followed by the femoral and jugular. Seldinger technique with direct radiation control in the operating room is used.

DEVICEPICC

The inclusion of any PICC is an aseptic technique, so hand washing, mask, cap is required, sterile gloves and scoping insertion using sterile drapes. The skin disinfection is carried out with 2% chlorhexidine alcohol 17, to be dried completely before insertion of the catheter (30 seconds). No prophylactic antibiotic was administered before insertion. PICC vein of choice is the basilica vein with help of Ecography in the interventional radiology room.

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male and female patients ≥ 18 years. * Patients hospitalized at our institution requiring at least 6 days of intravenous treatment in a conventional ward of our hospital. * Signed informed consent by the patient and / or when necessary parent / legal guardian.

Exclusion criteria

* Patients with bacteremia at the time of catheter insertion. * Patients admitted to hematology or intensive care units, for considered a type of patient characteristics very different from other patients. * Patients with severe clinical situation. * Patients in whom peripheral venous access is technically impossible, patients outpatient and express refusal of the patient. * Pregnant patients.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with Bacteraemia30 daysNumber of participants with Bacteraemia from insertion until 30 days after remove of the catheter

Secondary

MeasureTime frameDescription
morbidities in catheter insertion1 dayNumber of participants with complications during catheter insertion
Comparison of morbidities during manipulation of the catheters30 daysNumber of participants with complications during manipulation of the catheters
30 days Mortality30 daysNumber of died participants
Visual analogic scale of Pain30 daysVisual analogic scale of Pain in site of insertion from insertion until remove of the catheter
Health-care costs30 daysEconomic study of the whole procedure including complications

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026