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Completed

NCT Number: NCT02970409

Heparin Versus Saline in Peripheral Venous Catheter

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.

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Key information

Conditions

Catheter-Related Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Internal Medicine Department HGU Gregorio Marañón

Madrid, 28007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • hypersensibility to heparin
  • active hemorrhage
  • coagulation alterations

Treatment and study plan

Saline

Device

catheter lock using saline

Heparin

Device

catheter lock using Heparin

Primary outcomes

  1. complications

    Time frame: 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 outcomes

  1. catheter related infection rate

    Time frame: Through study completion( estimated 2 year after Last patient in)

    episodes of catheter related infection against number of days of exposure to catheter

  2. adverse events(number of catheter obstructions and coagulation alterations)

    Time frame: Through study completion (2 year afterLast patient in)

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Gregorio Marañon

Other

Collaborators

  • Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 22, 2016
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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