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GREENWATER 2.0: Reducing Iodinated Contrast Agents in Hospital Wastewater (GREENWATER 2)

19. juni 2026 oppdatert av: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

416

Kontakter og plasseringer

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Studiekontakt

Studiesteder

    • MI
      • Milan, MI, Italia, 20157

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult outpatients aged 18 years or older undergoing clinically indicated contrast-enhanced CT scans with iodinated contrast agents at IRCCS Ospedale Galeazzi - Sant'Ambrogio. Participants will receive standard clinical care, with no modification to the CT protocol or contrast administration. The only study-specific procedure is the post-contrast use of a dedicated urine collection device after an approximately 60-minute waiting period.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient Acceptance and Compliance With Post-Contrast Urine Collection
Tidsramme: 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.
At the time of the CT examination, up to 60 minutes after contrast injection

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Potential Recovery of Iodinated Contrast Agent From Collected Urine
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. mars 2026

Primær fullføring (Antatt)

1. september 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

27. mai 2026

Først innsendt som oppfylte QC-kriteriene

27. mai 2026

Først lagt ut (Faktiske)

2. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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