Actively Recruiting
Safe-Infusion Study
Led by Interlinked AB · Updated on 2024-12-16
548
Participants Needed
2
Research Sites
48 weeks
Total Duration
On this page
Sponsors
I
Interlinked AB
Lead Sponsor
P
Parc Sanitari Sant Joan de Déu
Collaborating Sponsor
AI-Summary
What this Trial Is About
Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or dislodgement. These complications can collectively be named mechanical complications. This study aims to assess a new device's effectiveness in reducing mechanical complications associated with PIVCs through a non-inferiority randomized trial at two sites. A total of 548 patients will be recruited, with primary outcomes focused on complication rates and secondary outcomes examining adverse events, healthcare feedback, and economic impacts.
CONDITIONS
Official Title
Safe-Infusion Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient has or will get a vascular access device (VAD) expected to be used for continuous or intermittent IV infusion therapy. Continuous IV infusion is defined as an infusion 2h and intermitted as an infusion lasting 15min to <2h.
- 18 years of age or older
- Speak and understand local language
- VADs already in place when the patient is admitted to the ward should not present with phlebitis or infiltration or occlusion
- Participants have signed the informed consent or have a legal authorized representative (LAR) who has provided this consent
You will not qualify if you...
- The VAD is expected to be used for sampling only
- Pregnancy
- Unable to obtain informed consent or without an available LAR to provide surrogate informed consent
- Patients under palliative care
- Bolus IV infusion, defined as an infusion time of <15 min
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Centro Hospitalar e Universitário de Coimbra
Coimbra, Portugal, 3000-075
Actively Recruiting
2
Parc Sanitari Sant Joan de Déu
Barcelona, Spain, 08830
Completed
Research Team
C
Christopher Blacker, Medical Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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