Mechanisms of Acute Kidney Injury in Severe Infections

Recruiting

• Conditions: Sepsis; Positron Emission Tomography (PET); AKI - Acute Kidney Injury
• Interventions: Radiation: Positron emission tomography (PET)

• Registration Number: NCT06372444
• Lead Sponsor: Uppsala University Hospital

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.

Study Timeline

• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Study Start: 2024-05-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-04-03
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with sepsis and AKI	Positron emission tomography (PET)	-
Healthy controls	Positron emission tomography (PET)	-

Primary Outcome Measures

Name	Time	Method
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)	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)	PET performed within 10 days of AKI	vs controls

Trial Locations

Locations (1)

Uppsala university hospital; 🇸🇪 Uppsala, Sweden