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Clinical Trials/NCT02970409
NCT02970409
Completed
Not Applicable

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

Hospital General Universitario Gregorio Marañon1 site in 1 country354 target enrollmentOctober 17, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Catheter-Related Infections
Sponsor
Hospital General Universitario Gregorio Marañon
Enrollment
354
Locations
1
Primary Endpoint
complications
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 17, 2015
End Date
October 30, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital General Universitario Gregorio Marañon
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

  • 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 Sites (1)

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