Heparin Versus Saline in Peripheral Venous Catheter

Catheter-Related Infections Clinical Trial

Official title:

A Randomized Study to Test Peripheral Venous Catheter Lock Therapy With Either Heparin or Saline in Patients Admitted to the Internal Medicine Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970409
• Other study ID #: FIBHGM-ECNC002-2014
• Status: Completed
• Phase: N/A
• Start date: October 17, 2015
• Est. completion date: October 30, 2017

Study information

• Verified date: December 2018
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter. Patients will be randomized to either receive heparin or saline. The investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.

Description:

The need of use of peripheral venous catheters and the importance of a proper management to avoid catheter colonization or phlebitis requires two possible preventive approaches: lock therapy with heparin or saline.

Heparin demonstrated its efficacy in central venous catheters, but there are still controversies of whether it is useful in peripheral venous catheters.

Objectives To compare the efficacy of heparin in peripheral venous catheters lock versus saline for the prevention of colonization and phlebitis in patients admitted to an Internal Medicine Department.

Methods: A clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter.

Patients will be randomized to either receive heparin or saline. The investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with inserted PV Catheter within 24h from admission in internal medicine

Exclusion Criteria:

• hypersensibility to heparin

• active hemorrhage

• coagulation alterations

Related Conditions & MeSH terms

• Catheter-Related Infections

Intervention

Device:
• saline
catheter lock using saline
• Heparin
catheter lock using Heparin

Locations

Country	Name	City	State
Spain	Internal Medicine Department HGU Gregorio Marañón	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon	Fundación para la Investigación Biomédica del Hospital Gregorio Maranon, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications	prevention of colonization(superficial and tip culture) and phlebitis(visual inflammation of entrance of catheter insertion) .	Daily from catheter insertion until catheter withdraw(estimated 10 days)
Secondary	catheter related infection rate	episodes of catheter related infection against number of days of exposure to catheter	Through study completion( estimated 2 year after Last patient in)
Secondary	adverse events(number of catheter obstructions and coagulation alterations)		Through study completion (2 year afterLast patient in)