Heparin Versus Saline in Peripheral Venous Catheter

Sponsor

Hospital General Universitario Gregorio Marañon (Other)

Overall Status

Completed

CT.gov ID

NCT02970409

Collaborator

Instituto de Salud Carlos III (Other), Fundación para la Investigación Biomédica del Hospital Gregorio Maranon (Other)

354

Enrollment

Location

Arms

24.4

Actual Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Catheter-Related Infections	Device: saline Device: Heparin	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

354 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 17, 2015

Actual Primary Completion Date :

Oct 30, 2017

Actual Study Completion Date :

Oct 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: heparin Catheter Lock Therapy with Heparin	Device: Heparin catheter lock using Heparin
Experimental: saline Catheter Lock Therapy with saline	Device: saline catheter lock using saline

Arm

Intervention/Treatment

Active Comparator: heparin

Catheter Lock Therapy with Heparin

Device: Heparin

catheter lock using Heparin

Experimental: saline

Catheter Lock Therapy with saline

Device: saline

catheter lock using saline

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

hypersensibility to heparin
active hemorrhage
coagulation alterations

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Internal Medicine Department HGU Gregorio Marañón	Madrid		Spain	28007

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital General Universitario Gregorio Marañon

ClinicalTrials.gov Identifier:

NCT02970409

Other Study ID Numbers:

FIBHGM-ECNC002-2014

First Posted:

Nov 22, 2016

Last Update Posted:

Dec 20, 2018

Last Verified:

Dec 1, 2018

Additional relevant MeSH terms:

Catheter-Related Infections

Heparin

Study Results

No Results Posted as of Dec 20, 2018