Status:
COMPLETED
Concept Elicitation and Patient Experience Mapping in SA-AKI
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Sepsis-associated Acute Kidney Injury
Eligibility:
All Genders
18-85 years
Brief Summary
This is a concept elicitation study on patient's experiences of Sepsis-associated Acute Kidney Injury (SA-AKI)
Detailed Description
The purpose of this study is to elicit concepts of interests in patients who experienced SA-AKI. The study also aims to map experiences from patient and caregiver perspectives, including treatment pat...
Eligibility Criteria
Inclusion
- Potential participants who were diagnosed with SA-AKI (KDIGO stage I, II or III) must meet the following eligibility criteria:
- ≥18 to ≤ 85 years of age
- First diagnosis of SA-AKI at least 6 months prior to screening date, but no more than 10 years
- Admitted due to sepsis and/or AKI to intensive care unit (ICU), intermediate care unit (IMCU), or high-dependency care unit, or developed sepsis and/or AKI during their inpatient hospital stay.
- Resident of country of study (US or Germany)
- Access to computer, tablet, or smartphone with internet connection
- Willing to participate in an audio recorded interview
- Participants will be required to present confirmation of diagnosis (COD) rather than relying on a self-reported diagnosis. Sepsis and AKI diagnoses will be confirmed through one of the following:
- Copy of medical records (e.g., portable document format \[PDF\] file of electronic health record)
- Physician confirmation of diagnosis of sepsis and AKI (post-sepsis)
- Potential caregiver participants must meet the following criteria:
- ≥18 to ≤ 85 years of age
- Primary caregiver/care-partner for eligible participant who experienced SA-AKI
- Resident of country of study (US or Germany)
- Access to computer, tablet, or smartphone with internet connection
- Willing to participate in an audio recorded interview
Exclusion
- Potential participants are not eligible if they meet any of the following criteria:
- Less than age of majority in locality (Participant is not considered an adult in their country or region)
- Not willing to participate in an audio recorded interview
- Not able to participate in the interview or complete required study surveys, based on the discretion of the study team
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT07180238
Start Date
May 1 2025
End Date
September 30 2025
Last Update
December 12 2025
Active Locations (1)
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1
Novartis Investigative Site
East Hanover, New Jersey, United States, 07936-1080