Heparin Versus Saline in Peripheral Venous Catheter

Not Applicable

Completed

• Conditions: Catheter-Related Infections
• Interventions: Device: Heparin; Device: saline

• Registration Number: NCT02970409
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-10-15
• Study Start: 2015-10-17
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-22
• Primary Completion: 2017-10-30
• Study Completion: 2017-10-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

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

Exclusion Criteria

• hypersensibility to heparin
• active hemorrhage
• coagulation alterations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
heparin	Heparin	Catheter Lock Therapy with Heparin
saline	saline	Catheter Lock Therapy with saline

Primary Outcome Measures

Name	Time	Method
complications	Daily from catheter insertion until catheter withdraw(estimated 10 days)	prevention of colonization(superficial and tip culture) and phlebitis(visual inflammation of entrance of catheter insertion) .

Secondary Outcome Measures

Name	Time	Method
catheter related infection rate	Through study completion( estimated 2 year after Last patient in)	episodes of catheter related infection against number of days of exposure to catheter
adverse events(number of catheter obstructions and coagulation alterations)	Through study completion (2 year afterLast patient in)

Trial Locations

Locations (1)

Internal Medicine Department HGU Gregorio Marañón; 🇪🇸 Madrid, Spain