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Recruiting NCT06372444

Mechanisms of Acute Kidney Injury in Severe Infections

Observational Sepsis AKI - Acute Kidney Injury Positron Emission Tomography (PET)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Positron emission tomography (PET).
Who it may be relevant to
Registry conditions: Sepsis, AKI - Acute Kidney Injury, Positron Emission Tomography (PET). Basic parameters: from 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Sweden · 1 center
  • Uppsala university hospital — Uppsala

Identifiers

NCT: NCT06372444 · 995725

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗