NCT02538159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

September 2, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2017

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

April 23, 2015

Last Update Submit

October 23, 2018

Conditions

Catheter Related Infections

Keywords

Non-tunneled Central venous catheterBacteraemiaPeripherally inserted central venous catheter

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Bacteraemia

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

    30 days

Secondary Outcomes (5)

  • morbidities in catheter insertion

    1 day

  • Comparison of morbidities during manipulation of the catheters

    30 days

  • 30 days Mortality

    30 days

  • Visual analogic scale of Pain

    30 days

  • Health-care costs

    30 days

Study Arms (2)

Experimental CVC

EXPERIMENTAL

CVC insertion Non-tunneled Central venous catheter insertion

Device: CVC

Experimental PICC

EXPERIMENTAL

PICC insertion Peripherally inserted catheter

Device: PICC

Interventions

CVCDEVICE

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 CVC
PICCDEVICE

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.

Experimental PICC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Catheter-Related InfectionsToxemia

Condition Hierarchy (Ancestors)

Infections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

September 2, 2015

Study Start

September 2, 2015

Primary Completion

June 11, 2017

Study Completion

July 11, 2017

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

ES(1)