- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Luca Maria Sconfienza, MD, PhD
- Numéro de téléphone: +390283502227
- E-mail: io@lucasconfienza.it
Lieux d'étude
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MI
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Milan, MI, Italie, 20157
- Recrutement
- IRCCS Ospedale Galeazzi - Sant'Ambrogio
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Contact:
- Moreno Zanardo, PhD
- Numéro de téléphone: +390283502227
- E-mail: moreno.zanardo@grupposandonato.it
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient Acceptance and Compliance With Post-Contrast Urine Collection
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Potential Recovery of Iodinated Contrast Agent From Collected Urine
Délai: At the time of the CT examination, up to 60 minutes after contrast injection
|
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.
|
At the time of the CT examination, up to 60 minutes after contrast injection
|
Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GREENWATER 2.0
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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