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Heparin Versus Saline in Peripheral Venous Catheter

Primary Purpose

Catheter-Related Infections

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
saline
Heparin
Sponsored by
Hospital General Universitario Gregorio Marañon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter-Related Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Internal Medicine Department HGU Gregorio Marañón

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

heparin

saline

Arm Description

Catheter Lock Therapy with Heparin

Catheter Lock Therapy with saline

Outcomes

Primary Outcome Measures

complications
prevention of colonization(superficial and tip culture) and phlebitis(visual inflammation of entrance of catheter insertion) .

Secondary Outcome Measures

catheter related infection rate
episodes of catheter related infection against number of days of exposure to catheter
adverse events(number of catheter obstructions and coagulation alterations)

Full Information

First Posted
October 15, 2015
Last Updated
December 18, 2018
Sponsor
Hospital General Universitario Gregorio Marañon
Collaborators
Instituto de Salud Carlos III, Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
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1. Study Identification

Unique Protocol Identification Number
NCT02970409
Brief Title
Heparin Versus Saline in Peripheral Venous Catheter
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 17, 2015 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General Universitario Gregorio Marañon
Collaborators
Instituto de Salud Carlos III, Fundación para la Investigación Biomédica del Hospital Gregorio Maranon

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-Related Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
354 (Actual)

8. Arms, Groups, and Interventions

Arm Title
heparin
Arm Type
Active Comparator
Arm Description
Catheter Lock Therapy with Heparin
Arm Title
saline
Arm Type
Experimental
Arm Description
Catheter Lock Therapy with saline
Intervention Type
Device
Intervention Name(s)
saline
Intervention Description
catheter lock using saline
Intervention Type
Device
Intervention Name(s)
Heparin
Intervention Description
catheter lock using Heparin
Primary Outcome Measure Information:
Title
complications
Description
prevention of colonization(superficial and tip culture) and phlebitis(visual inflammation of entrance of catheter insertion) .
Time Frame
Daily from catheter insertion until catheter withdraw(estimated 10 days)
Secondary Outcome Measure Information:
Title
catheter related infection rate
Description
episodes of catheter related infection against number of days of exposure to catheter
Time Frame
Through study completion( estimated 2 year after Last patient in)
Title
adverse events(number of catheter obstructions and coagulation alterations)
Time Frame
Through study completion (2 year afterLast patient in)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with inserted PV Catheter within 24h from admission in internal medicine Exclusion Criteria: hypersensibility to heparin active hemorrhage coagulation alterations
Facility Information:
Facility Name
Internal Medicine Department HGU Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain

12. IPD Sharing Statement

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Heparin Versus Saline in Peripheral Venous Catheter

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