Acute Kidney Injury Due to SepsisNCT05982340
Endogenous Lithium Clearance in Acute Kidney Injury
An observational study of Acute Kidney Injury Due to Sepsis and Proximal Tubule Function, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Critically ill patients are at high risk of developing acute kidney injury (AKI). Lithium is freely filtrated at the glomerulus and almost completely reabsorbed in the proximal tubule, which provides a quantitative estimation of proximal tubule reabsorption. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury Due to Sepsis, Proximal Tubule Function, Lithium Clearance
- What is being tested?
- Lithium clearance
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 1 Aug 2023to 20 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Critically ill patients and healthy controls
Who may be able to join
- ICU patients diagnosed with AKI, without AKI and healthy controls
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Critically ill patients are at high risk of developing acute kidney injury (AKI). Lithium is freely filtrated at the glomerulus and almost completely reabsorbed in the proximal tubule, which provides a quantitative estimation of proximal tubule reabsorption. The investigators hypothesized that endogenous lithium reabsorption is impaired in the early stages of critical illness.
Investigators would like to study 10 ICU patients with AKI diagnosed, 10 patients without AKI, and 10 healthy controls.
Read the detailed description
Blood and urine samples will be obtained at 08:00, 14:00 and 20:00 during one day. Renal clearance of creatinine (CCr) and lithium will be calculated.
- Being tested
- Lithium clearance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium clearanceDiagnostic test
Blood and urine samples
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | ICU patients with AKI Receives: Diagnostic Test: Lithium clearance | |
| Group 2 | ICU patients with normal renal function Receives: Diagnostic Test: Lithium clearance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal lithium clearance
Clearance of lithium from the body
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Aug 2023
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney Injury Due to 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars MG Ytrebø, MD PhD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982340
- Sponsor's protocol ID
- 03055 PVO
- Status last verified
- May 2025
- First submitted
- 31 Jul 2023
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jakobsen K, Backmann H, Nicolaysen NG, Zahn R, Huber S, Skogen V, Kildal AB, Ytrebo LM. Renal clearance of endogenous lithium as a marker of proximal tubule function in sepsis and sepsis-associated acute kidney injury : A prospective single-centre study. BMC Nephrol. 2026 Jan 8;27(1):93. doi: 10.1186/s12882-026-04743-1.
PubMed 41507830
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endogenous Lithium Clearance in Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05982340
- Acronym / sponsor ID
- 03055 PVO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 8 Aug 2023 (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.
Critically ill patients are at high risk of developing acute kidney injury (AKI). Lithium is freely filtrated at the glomerulus and almost completely reabsorbed in the proximal tubule, which provides a quantitative estimation of proximal tubule reabsorption. The investigators hypothesized that endogenous lithium reabsorption is impaired in the early stages of critical illness.
Investigators would like to study 10 ICU patients with AKI diagnosed, 10 patients without AKI, and 10 healthy controls.
Detailed description
Blood and urine samples will be obtained at 08:00, 14:00 and 20:00 during one day. Renal clearance of creatinine (CCr) and lithium will be calculated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Lithium clearanceICU patients with AKI |
| Group 2 | – | Diagnostic Test: Lithium clearanceICU patients with normal renal function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients and healthy controls
Key inclusion criteria (1 listed)
- ICU patients diagnosed with AKI, without AKI and healthy controls
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Lithium clearanceBlood and urine samples | Diagnostic test | Group 1, Group 2 |
Primary outcome
Renal lithium clearance
Time frame: 2 days
Clearance of lithium from the body
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Derived from this study: PubMed 41507830Jakobsen K, Backmann H, Nicolaysen NG, Zahn R, Huber S, Skogen V, Kildal AB, Ytrebo LM. Renal clearance of endogenous lithium as a marker of proximal tubule function in sepsis and sepsis-associated acute kidney injury : A prospective single-centre study. BMC Nephrol. 2026 Jan 8;27(1):93. doi: 10.1186/s12882-026-04743-1.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lars MG Ytrebø, MD PhD principal investigator
University Hospital of North Norway
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 Acute Kidney Injury Due to Sepsis and Proximal Tubule Function, run by University Hospital of North Norway at 1 site in Norway.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jun 2025. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal lithium clearance (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05982340, which also lists 1 linked publication.
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 22 Jun 2025.