Safety and Bacteraemia Between Peripherally Inserted and Central Inserted Catheters.

Catheter Related Infections Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538159
• Other study ID #: IIBSP-CAT-2014-36
• Status: Completed
• Phase: N/A
• Start date: September 2, 2015
• Est. completion date: July 11, 2017

Study information

• Verified date: October 2018
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: July 11, 2017
• Est. primary completion date: June 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacteremia
• Catheter Related Infections
• Catheter-Related Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

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