MedDataX Logo

Mechanisms of Acute Kidney Injury in Severe Infections

NCT ID: NCT06372444

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with sepsis and AKI

Positron emission tomography (PET)

Intervention Type RADIATION

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

Healthy controls

Positron emission tomography (PET)

Intervention Type RADIATION

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Positron emission tomography (PET)

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

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uppsala University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Miklos Lipcsey

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uppsala university hospital

Uppsala, , Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Miklos Lipcsey, MD, PhD

Role: CONTACT

Phone: +46186110000

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Miklos Lipcsey, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

995725

Identifier Type: -

Identifier Source: org_study_id