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

Primary Purpose

Catheter Related Infections

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CVC
PICC
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Catheter Related Infections focused on measuring Non-tunneled Central venous catheter, Bacteraemia, Peripherally inserted central venous catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental CVC

Experimental PICC

Arm Description

CVC insertion Non-tunneled Central venous catheter insertion

PICC insertion Peripherally inserted catheter

Outcomes

Primary Outcome Measures

Number of participants with Bacteraemia
Number of participants with Bacteraemia from insertion until 30 days after remove of the catheter

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2015
Last Updated
October 23, 2018
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT02538159
Brief Title
Safety and Bacteraemia Between Peripherally Inserted and Central Inserted Catheters.
Acronym
PYCBAC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2, 2015 (Actual)
Primary Completion Date
June 11, 2017 (Actual)
Study Completion Date
July 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Related Infections
Keywords
Non-tunneled Central venous catheter, Bacteraemia, Peripherally inserted central venous catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental CVC
Arm Type
Experimental
Arm Description
CVC insertion Non-tunneled Central venous catheter insertion
Arm Title
Experimental PICC
Arm Type
Experimental
Arm Description
PICC insertion Peripherally inserted catheter
Intervention Type
Device
Intervention Name(s)
CVC
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PICC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with Bacteraemia
Description
Number of participants with Bacteraemia from insertion until 30 days after remove of the catheter
Time Frame
30 days
Secondary Outcome Measure Information:
Title
morbidities in catheter insertion
Description
Number of participants with complications during catheter insertion
Time Frame
1 day
Title
Comparison of morbidities during manipulation of the catheters
Description
Number of participants with complications during manipulation of the catheters
Time Frame
30 days
Title
30 days Mortality
Description
Number of died participants
Time Frame
30 days
Title
Visual analogic scale of Pain
Description
Visual analogic scale of Pain in site of insertion from insertion until remove of the catheter
Time Frame
30 days
Title
Health-care costs
Description
Economic study of the whole procedure including complications
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

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Safety and Bacteraemia Between Peripherally Inserted and Central Inserted Catheters.

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