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NCT Number: NCT06372444

Mechanisms of Acute Kidney Injury in Severe Infections

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positron Emission Tomography (PET)

Radiation

Assessment of blood flow with marked water and assessment of neutrophil presence with neutrophil elastase tracer + CT

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Miklos Lipcsey, MD, PhD

CONTACT

[email protected]

+46186110000

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Registry information

Acronym: PET-AKI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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