NCT02970409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

October 17, 2015

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

October 15, 2015

Last Update Submit

December 18, 2018

Conditions

Catheter-Related Infections

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • catheter related infection rate

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

  • adverse events(number of catheter obstructions and coagulation alterations)

    Through study completion (2 year afterLast patient in)

Study Arms (2)

heparin

ACTIVE COMPARATOR

Catheter Lock Therapy with Heparin

Device: Heparin

saline

EXPERIMENTAL

Catheter Lock Therapy with saline

Device: saline

Interventions

salineDEVICE

catheter lock using saline

saline
HeparinDEVICE

catheter lock using Heparin

heparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • hypersensibility to heparin
  • active hemorrhage
  • coagulation alterations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal Medicine Department HGU Gregorio Marañón

Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2015

First Posted

November 22, 2016

Study Start

October 17, 2015

Primary Completion

October 30, 2017

Study Completion

October 30, 2017

Last Updated

December 20, 2018

Record last verified: 2018-12

Locations

ES(1)