Safety and Bacteraemia Between Peripherally Inserted and Central Inserted Catheters. (PYCBAC)

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

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.

Study Overview

• Status: Completed
• Conditions: Catheter Related Infections
• Intervention / Treatment: Device: CVC; Device: PICC

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental CVC; CVC insertion Non-tunneled Central venous catheter insertion	Device: CVC; 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.
Experimental: Experimental PICC; PICC insertion Peripherally inserted catheter	Device: PICC; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Bacteraemia	Number of participants with Bacteraemia from insertion until 30 days after remove of the catheter	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morbidities in catheter insertion	Number of participants with complications during catheter insertion	1 day
Comparison of morbidities during manipulation of the catheters	Number of participants with complications during manipulation of the catheters	30 days
30 days Mortality	Number of died participants	30 days
Visual analogic scale of Pain	Visual analogic scale of Pain in site of insertion from insertion until remove of the catheter	30 days
Health-care costs	Economic study of the whole procedure including complications	30 days

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2015
• Primary Completion (Actual): June 11, 2017
• Study Completion (Actual): July 11, 2017

Study Registration Dates

• First Submitted: April 23, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): October 25, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Bacteraemia; Non-tunneled Central venous catheter; Peripherally inserted central venous catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia; Catheter-Related Infections
• Other Study ID Numbers: IIBSP-CAT-2014-36