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OpenTrials
Completed

NCT Number: NCT02538159

Safety and Bacteraemia Between Peripherally Inserted and Central Inserted Catheters.

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.

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Key information

Conditions

Catheter Related Infections Catheter-Related Infections Infections Toxemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CVC

Device

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.

PICC

Device

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 outcomes

  1. Number of participants with Bacteraemia

    Time frame: 30 days

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

Secondary outcomes

  1. morbidities in catheter insertion

    Time frame: 1 day

    Number of participants with complications during catheter insertion

  2. Comparison of morbidities during manipulation of the catheters

    Time frame: 30 days

    Number of participants with complications during manipulation of the catheters

  3. 30 days Mortality

    Time frame: 30 days

    Number of died participants

  4. Visual analogic scale of Pain

    Time frame: 30 days

    Visual analogic scale of Pain in site of insertion from insertion until remove of the catheter

  5. Health-care costs

    Time frame: 30 days

    Economic study of the whole procedure including complications

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Acronym: PYCBAC

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 2, 2015
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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