Mechanisms of Acute Kidney Injury in Severe Infections

NCT06372444 | Recruiting

• 1 other identifier: 995725
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Patients with sepsis and AKI

Radiation: Positron emission tomography (PET)

Healthy controls

Radiation: Positron emission tomography (PET)

Interventions

Positron emission tomography (PET) RADIATION

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

Healthy controls; Patients with sepsis and AKI

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients with sepsis and AKI and healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University Hospital: lead

Study Sites (1)

Uppsala university hospital

Uppsala, 75185, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and urine

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Miklos Lipcsey, MD, PhD

CONTACT

+46186110000; miklos.lipcsey@uu.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 18, 2024
• Study Start: May 1, 2024
• Primary Completion: April 3, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)