Heparin Versus Saline in Peripheral Venous Catheter | NCT02970409

Studies
Heparin Versus Saline in Peripheral Venous Catheter

NCT02970409

Sponsor

Hospital General Universitario Gregorio Marañon

Status

Completed

Last Update Posted

Dec 20, 2018Actual

Enrollment

354Actual

Phase

Not Applicable

Conditions

Catheter-Related Infections

Interventions

saline
Heparin

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2015Actual

Primary Completion Date

Oct 30, 2017Actual

Completion Date

Oct 30, 2017Actual

First Submitted Date

Oct 15, 2015

First Submission Date that Met QC Criteria

Nov 21, 2016

First Posted Date

Nov 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2018

Last Update Posted Date

Dec 20, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Hospital General Universitario Gregorio MarañonOTHER

Collaborators

Name	Class
Instituto de Salud Carlos III	OTHER_GOV
Fundación para la Investigación Biomédica del Hospital Gregorio Maranon	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

354Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
heparin	Active Comparator	Catheter Lock Therapy with Heparin	Device: Heparin
saline	Experimental	Catheter Lock Therapy with saline	Device: saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
saline	Device	catheter lock using saline	saline
Heparin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Internal Medicine Department HGU Gregorio Marañón		Madrid		28007	Spain

Condition Browse Module

MeSH Terms

ID	Term
D055499	Catheter-Related Infections

Ancestor Terms

ID	Term
D007239	Infections

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