Mechanisms of Acute Kidney Injury in Severe Infections (PET-AKI)

December 3, 2024 updated by: Miklos Lipcsey, Uppsala University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Recruiting
        • Uppsala University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Critically ill patients with sepsis and AKI and healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls
Radiation: Positron emission tomography (PET)
Assessment of blood flow with marked water and assessment of neutrophil presence with neutrophil elastase tracer + CT
Patients with sepsis and AKI
Radiation: Positron emission tomography (PET)
Assessment of blood flow with marked water and assessment of neutrophil presence with neutrophil elastase tracer + CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
vs controls
PET performed within days of AKI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

April 3, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 995725

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The underlying data for this study will not be made publicly available. However, the data may be acquired from the authors upon reasonable request after permission from the Swedish ethical review authority and under the limitations of the general data protection act of the European Union.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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