Heparin Versus Saline in Peripheral Venous Catheter

NCT ID: NCT02970409

Last Updated: 2018-12-20

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

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-17

Study Completion Date

2017-10-30

Brief Summary

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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

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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.

Conditions

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Catheter-Related Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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heparin

Catheter Lock Therapy with Heparin

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DEVICE

catheter lock using Heparin

saline

Catheter Lock Therapy with saline

Group Type EXPERIMENTAL

saline

Intervention Type DEVICE

catheter lock using saline

Interventions

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saline

catheter lock using saline

Intervention Type DEVICE

Heparin

catheter lock using Heparin

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* hypersensibility to heparin
* active hemorrhage
* coagulation alterations
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Fundación para la Investigación Biomédica del Hospital Gregorio Maranon

OTHER

Sponsor Role collaborator

Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Internal Medicine Department HGU Gregorio Marañón

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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FIBHGM-ECNC002-2014

Identifier Type: -

Identifier Source: org_study_id

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