SepsisPET-AKINCT06372444
Mechanisms of Acute Kidney Injury in Severe Infections
An observational study of Sepsis and AKI - Acute Kidney Injury, run by Uppsala University Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, AKI - Acute Kidney Injury, Positron Emission Tomography (PET)
- What is being tested?
- Positron emission tomography (PET)
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Critically ill patients with sepsis and AKI and healthy volunteers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala university hospital
Uppsala, 75185
Miklos Lipcsey, MD, +4618611000, miklos.lipcsey@uu.se
About this study
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.
Read the 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.
- Being tested
- Positron emission tomography (PET)
- Medical subject headings
- Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography (PET)Radiation
Assessment of blood flow with marked water and assessment of neutrophil presence with neutrophil elastase tracer + CT
| Study group | Role | What they receive |
|---|---|---|
| Patients with sepsis and AKI | Not described Receives: Radiation: Positron emission tomography (PET) | |
| Healthy controls | Not described Receives: Radiation: Positron emission tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal perfusion in patients with sepsis and acute kidney injury (AKI) measured by 15O-labeled water in dynamic positron emission tomography (PET)
vs controls
Measured: 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
Measured: PET performed within days of AKI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 May 2024
- Primary completion3 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miklos Lipcsey, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372444
- Sponsor's protocol ID
- 995725
- Acronym
- PET-AKI
- Status last verified
- Dec 2024
- First submitted
- 25 Mar 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Acute Kidney Injury in Severe Infections
- ClinicalTrials.gov ID
- NCT06372444
- Acronym / sponsor ID
- PET-AKI / 995725
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 3 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with sepsis and AKI | – | Radiation: Positron emission tomography (PET) |
| Healthy controls | – | Radiation: Positron emission tomography (PET) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with sepsis and AKI and healthy volunteers
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron emission tomography (PET)Assessment of blood flow with marked water and assessment of neutrophil presence with neutrophil elastase tracer + CT | Radiation | Healthy controls, Patients with sepsis and AKI |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and AKI - Acute Kidney Injury, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miklos Lipcsey, MD, PhD (+46186110000, miklos.lipcsey@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.