Skip to main content
Clinical Trials/NCT06372444
NCT06372444
Recruiting
Not Applicable

Mechanisms of Acute Kidney Injury in Severe Infections

Uppsala University Hospital1 site in 1 country15 target enrollmentMay 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
Uppsala University Hospital
Enrollment
15
Locations
1
Primary Endpoint
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)
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
June 30, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Miklos Lipcsey

Professor

Uppsala University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Time Frame: PET performed within days of AKI

vs controls

Renal perfusion in patients with sepsis and acute kidney injury (AKI) measured by 15O-labeled water in dynamic positron emission tomography (PET)

Time Frame: PET performed within 10 days of AKI

vs controls

Study Sites (1)

Loading locations...

Similar Trials