- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07620093
GREENWATER 2.0: Reducing Iodinated Contrast Agents in Hospital Wastewater (GREENWATER 2)
GREENWATER 2.0: Cutting Edge Solution for Reducing Iodinated Contrast Agents Via Post-Administration Collection Device
The goal of this observational study is to learn if using a dedicated urine collection device after CT scans can help reduce the amount of iodinated contrast agent released into hospital wastewater in adult outpatients undergoing contrast-enhanced CT scans.
The main questions it aims to answer are:
- Does the dedicated urine collection device improve patient acceptance and compliance with post-contrast urine collection?
- How much iodinated contrast agent can be recovered from urine collected after CT scans?
Participants will:
- Have their planned CT scan with iodinated contrast agent as part of their regular medical care.
- Wait in the radiology department for about 60 minutes after the contrast injection.
- Use a dedicated urine collection device before leaving the hospital.
- Answer short questions about their experience with the device.
This does not change the CT scan, the contrast agent used, or the standard clinical imaging procedure. The only additional procedure is the use of the dedicated urine collection device after the scan.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
GREENWATER 2.0 is a single-center, prospective observational study with an additional urine collection procedure. The study will be conducted in the diagnostic imaging department of IRCCS Ospedale Galeazzi - Sant'Ambrogio and will include adult outpatients undergoing clinically indicated contrast-enhanced CT scans with iodinated contrast agents.
Iodinated contrast agents are widely used in CT imaging to improve diagnostic accuracy. After intravenous administration, these agents are predominantly eliminated unchanged through urine. Because conventional wastewater treatment may not fully remove iodinated contrast agent residues, urine collection shortly after contrast administration may represent a practical strategy to reduce their release into hospital wastewater.
The study builds on the previous GREENWATER study, which showed high patient willingness to participate in a sustainability-focused urine collection protocol after contrast-enhanced imaging. In GREENWATER 2.0, a dedicated urine collection device will be installed in the radiology department to make the collection process more practical and integrated into the clinical workflow.
Participants will undergo their scheduled CT scan according to standard clinical practice. The indication for the CT scan, the choice of iodinated contrast agent, the contrast dose, and the imaging protocol will not be modified for research purposes. After contrast injection, participants will be asked to remain in the radiology department for about 60 minutes and then use the dedicated urine collection device before leaving the hospital.
The study will evaluate whether this workflow is acceptable and feasible for patients in routine radiology practice. It will also assess the potential recovery of iodinated contrast agent residues from the collected urine. Additional information will be collected on the contrast agent administered, the volume of urine collected, the time between CT examination and device use, and patient-reported experience with the device, including comfort, ease of use, cleanliness, privacy, odor, waiting time perception, and clarity of instructions.
The study is expected to provide evidence on the feasibility of using a dedicated urine collection device in a hospital radiology department as a sustainability measure to reduce the environmental impact of iodinated contrast agents. The planned sample size is 416 participants, with recruitment expected to last approximately 12 months. The total study duration is expected to be approximately 18 months, including recruitment, data analysis, and preparation of the final study report.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Luca Maria Sconfienza, MD, PhD
- Número de teléfono: +390283502227
- Correo electrónico: io@lucasconfienza.it
Ubicaciones de estudio
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MI
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Milan, MI, Italia, 20157
- Reclutamiento
- IRCCS Ospedale Galeazzi - Sant'Ambrogio
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Contacto:
- Moreno Zanardo, PhD
- Número de teléfono: +390283502227
- Correo electrónico: moreno.zanardo@grupposandonato.it
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adult patients aged 18 years or older.
- Patients scheduled for a clinically indicated contrast-enhanced CT scan with iodinated contrast agent.
- Patients able to provide written informed consent.
- Patients willing to wait approximately 60 minutes after contrast injection before using the dedicated urine collection device.
Exclusion Criteria:
- Patients unable to use the dedicated urine collection device for urine collection.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Adult Outpatients Undergoing Contrast-Enhanced CT
Adult outpatients scheduled for clinically indicated contrast-enhanced CT scans with iodinated contrast agents.
Participants will undergo their standard CT examination with no change to the imaging protocol or contrast administration.
After contrast injection, they will be asked to wait approximately 60 minutes in the radiology department and then use a dedicated urine collection device before leaving the hospital.
|
A dedicated urine collection device installed in the radiology department for use after contrast-enhanced CT scans.
Participants will undergo their CT scan according to standard clinical practice, with no change to the imaging protocol, contrast agent selection, or contrast administration.
After iodinated contrast injection, participants will be asked to wait approximately 60 minutes and then use the dedicated device before leaving the hospital.
The collected urine will be used to assess the potential recovery of iodinated contrast agent residues and the feasibility of this workflow in routine radiology practice.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient Acceptance and Compliance With Post-Contrast Urine Collection
Periodo de tiempo: At the time of the CT examination, up to 60 minutes after contrast injection
|
Proportion of eligible participants who agree to participate in the study and complete the post-contrast urine collection procedure using the dedicated urine collection device after contrast-enhanced CT.
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At the time of the CT examination, up to 60 minutes after contrast injection
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Potential Recovery of Iodinated Contrast Agent From Collected Urine
Periodo de tiempo: At the time of the CT examination, up to 60 minutes after contrast injection
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Amount or proportion of iodinated contrast agent recovered from urine collected using the dedicated urine collection device after contrast-enhanced CT, based on the administered contrast agent and urine analysis.
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At the time of the CT examination, up to 60 minutes after contrast injection
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GREENWATER 2.0
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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