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Safe-Infusion Study

RecruitingNAAges 18 Years - anyAllInterlinked AB
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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
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What it tests

  • Intervention
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Where

2 sites
Centro Hospitalar e Universitário de Coimbra
Coimbra, Portugal
Parc Sanitari Sant Joan de Déu
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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