Safety and Bacteraemia Between Peripherally Inserted and Central Inserted Catheters.

NCT ID: NCT02538159

Last Updated: 2018-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-02

Study Completion Date

2017-07-11

Brief Summary

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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.

Detailed Description

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Conditions

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Catheter Related Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental CVC

CVC insertion Non-tunneled Central venous catheter insertion

Group Type EXPERIMENTAL

CVC

Intervention Type 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.

Experimental PICC

PICC insertion Peripherally inserted catheter

Group Type EXPERIMENTAL

PICC

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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IIBSP-CAT-2014-36

Identifier Type: -

Identifier Source: org_study_id

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