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NCT01382524 · ClinicalTrials.gov registry record

Peripheral Intravenous Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems

A clinical trial, sponsored by Solventum US.

Completed
Registry status
682
Enrollment target

NCT01382524: Completed study, sponsored by Solventum US.

NCT01382524 is a clinical trial that has completed, run by Solventum US. The registered enrollment target is 682 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01382524 has completed, sponsored by Solventum US.

COMPLETED
Registry status
682 participants
Enrollment target

Study Summary

Approximately 300 million short peripheral intravascular catheters (PIVs) were sold in the U.S. in 2009. These short (\< 3 inches) peripherally inserted IV catheters are vital for providing patients with needed: 1) fluid, electrolyte, nutrient and blood product replacement, 2) medicines and 3) diagnostic solutions (dyes). However, these IV catheters have inherent risks or potential complications which may result from poor catheter securement or stabilization. When a PIV catheter is not properly secured, motion and micro-motion within the vessel cause injury to the vein. This damage to the vein is a primary cause of phlebitis, a distressing complication of PIV therapy. Additional complications of inadequate stabilization of the PIV catheter are infiltration, leaking at the insertion site, pain, infection and dislodgement. According to Royer (2003), the most common reason for PIV catheter failure is infiltration and dislodgement. Infiltration is more dependent on keeping the extremity still, where phlebitis is dependent on injuries due to the chemical nature of the drugs and fluids infused or by the physical trauma to the endothelium from IV pushes. The results of these complications are costly and can be serious if another vein cannot be immediately accessed or if the infiltrated infusate causes tissue necrosis. An unscheduled restart of another PIV catheter causes a delay in patient treatment, patient discomfort, patient dissatisfaction, safety concerns, nursing interruptions and additional costs. Actual costs associated with PIV catheter restarts include materials and nursing resources; yet intangibles such as, treatment for patient complications and patient dissatisfaction may be far more costly. One way to reduce the incidence of PIV catheter-associated complications is to use technologies that help reduce catheter movement thereby improving catheter stabilization. In addition to stabilization platforms added to the peripheral IV catheter design, catheter stab

Primary Outcome

The primary endpoint for the study is the difference between the number and type of PIV-related complications (phlebitis, infiltration, dislodgement, leakage, local site infection and catheter line associated infection) between the two stabilization groups.

Trial Details

FieldValue
Enrollment Target 682 participants
Start Date 2011-06
Est. Completion 2012-09
Solventum US

41 total trials

What the finished NCT01382524 record still lists

NCT01382524 is an observational study that tracks outcomes without assigning an intervention. The registered 682 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT01382524 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01382524 about?

NCT01382524 is a clinical study titled "Peripheral Intravenous Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems". Approximately 300 million short peripheral intravascular catheters (PIVs) were sold in the U.S. in 2009. These short (\< 3 inches) peripherally inserted IV catheters are vital for providing patients with needed: 1) fluid, electrolyte, nutrient and blood product replacement, 2) medicines and 3) diagn...

What is the current status of trial NCT01382524?

This trial is currently completed. The enrollment target is 682 participants. The study started on 2011-06. Estimated completion is 2012-09.

Who is sponsoring clinical trial NCT01382524?

This trial is sponsored by Solventum US, which has 41 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01382524, the US trial registry maintained by the National Library of Medicine. NCT01382524 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.