Heparin Versus Saline in Peripheral Venous Catheter

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Catheter-Related Infections

Intervention / Treatment
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* Device: saline
* Device: Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with inserted PV Catheter within 24h from admission in internal medicine Exclusion Criteria: hypersensibility to heparin active hemorrhage coagulation alterations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: heparin<br>Catheter Lock Therapy with Heparin | Device: Heparin<br>* catheter lock using Heparin<br>|
| Experimental: saline<br>Catheter Lock Therapy with saline | Device: saline<br>* catheter lock using saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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) |  | Through study completion (2 year afterLast patient in) |