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NCT06372444 Clinical Trial

Mechanisms of Acute Kidney Injury in Severe Infections

Sepsis Clinical Trial

— PET-AKI  

Official title:
Mechanisms of Acute Kidney Injury in Severe Infections

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06372444
Other study ID # 995725
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date June 30, 2026

Study information
Verified date April 2024
Source Uppsala University Hospital
Contact Miklos Lipcsey, MD, PhD
Phone +46186110000
Email miklos.lipcsey@uu.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Renal perfusion and neutrophil-mediated inflammation will be assessed in the kidney in sepsis patients with acute kidney injury using positron emission tomography. For marked water will be used for renal perfusion and a newly developed PET tracer molecule (11C-GW457427) with specific binding to neutrophil elastase which provides a measure of the amount of infiltrating neutrophils in the renal parenchyma for inflammation. The study is performed in a PET-CT camera where anatomical imaging takes place at the same time as the PET examinations.

Description:

To study renal perfusion and neutrophil-mediated inflammation 10 critically ill patients with sepsis and acute kidney injury (AKI) and 5 healthy volunteers as controls will be recruited and examined at one time with marked water followed by neutrophil elastase tracer. At the same time, a CT scan is performed for anatomy. Plasma levels of inflammatory mediators will be measured. Clinical data will be collected. The endpoints are changes in renal perfusion and increased presence of neutrophil elastase in the renal parenchyma.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 15
Est. completion date June 30, 2026
Est. primary completion date April 3, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria: Patients with sepsis and AKI - > 30 years - At least AKI stage 1 according to KDIGO where the last plasma creatinine is measured within 24 hours of the examination Healthy volunteers - > 30 years - No previously known kidney disease - Normal plasma creatinine value Exclusion Criteria: - Chronic renal failure (CKD stage >3a) or dialysis - Instability in vital functions that makes PET-CT examination unsuitable - Claustrophobia or other reasons that make the patient unable to lie still during the examination. - Pregnancy and breastfeeding

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Positron emission tomography (PET)
Assessment of blood flow with marked water and assessment of neutrophil presence with neutrophil elastase tracer + CT

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Uppsala University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Renal perfusion in patients with sepsis and acute kidney injury (AKI) measured by 15O-labeled water in dynamic positron emission tomography (PET) vs controls PET performed within 10 days of AKI
Primary Presence of neutrophil elastase in the kidneys in patients with sepsis and acute kidney injury (AKI) by 11C-GW457427 measured with dynamic positron emission tomography (PET) vs controls PET performed within days of AKI
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