Acute Kidney InjuryNCT05648435
Lithium Clearance in Patients With High Risk of Acute Kidney Injury
An observational study of Acute Kidney Injury, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Renal lithium clearance is hypothesized to be a useful indicator of renal tubular function. In this study lithium clearance will be monitored in patients with sepsis associated acute kidney injury and in healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Lithium measures
- How many people
- 21 participants
- Where
- 1 siteNorway
- Study dates
- 7 Dec 2022to 31 Jan 2023
- How long will I take part?
- 1 Day
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Intensive care patients and healthy controls
Who may be able to join
- Sepsis diagnosed or suspected
- Age >18 years
- Previously healthy individuals
- Age >18 years
Who cannot join
- Oliguria or renal impairment due to other causes than sepsis. Pregnancy or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proximal Tubule Function in Septic Patients as Measured by Endogenous Lithium Clearance
Renal lithium clearance is hypothesized to be a useful indicator of renal tubular function.
In this study lithium clearance will be monitored in patients with sepsis associated acute kidney injury and in healthy controls.
Read the detailed description
Lithium is almost completely reabsorbed in the proximal tubule in parallel with sodium and water. What is not reabsorbed here is assumed to be fully excreted in urine, giving a reasonably accurate measurement of sodium reabsorption in the proximal tubule. Endogenous lithium clearance will be measured by inductively coupled plasma mass spectrometry (ICP-MS). The Gomez equations will be applied to calculate efferent arteriolar resistance, afferent arteriolar resistance, glomerular hydrostatic pressure, glomerular filtration pressure, and glomerular oncotic pressure. N-acetyl-β-D glucosaminidase (NAG) and NGAL, markers of tubular injury, will be measured by a spectrophotometric method using a commercially available kit. Routine blood and urine analyses will be performed at the Diagnostic Clinic Laboratory, University Hospital of North Norway, Tromsø.
- Conditions
- Acute Kidney Injury
- Being tested
- Lithium measures
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium measuresDiagnostic test
Measurements of lithium levels in blood and urine
| Study group | Role | What they receive |
|---|---|---|
| Sepsis patients | No interventions Receives: Diagnostic Test: Lithium measures | |
| Healthy controls | No interventions Receives: Diagnostic Test: Lithium measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal lithium clearance
Measurement of renal lithium clearance at 8AM, 2 PM, and 8 PM
Measured: Repeated measures between 07:00-20:00
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start7 Dec 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- 21 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648435
- Sponsor's protocol ID
- REK 536547
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Tubule Function in Septic Patients as Measured by Endogenous Lithium Clearance
- ClinicalTrials.gov ID
- NCT05648435
- Acronym / sponsor ID
- REK 536547
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 13 Dec 2022 (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 lithium clearance is hypothesized to be a useful indicator of renal tubular function.
In this study lithium clearance will be monitored in patients with sepsis associated acute kidney injury and in healthy controls.
Detailed description
Lithium is almost completely reabsorbed in the proximal tubule in parallel with sodium and water. What is not reabsorbed here is assumed to be fully excreted in urine, giving a reasonably accurate measurement of sodium reabsorption in the proximal tubule. Endogenous lithium clearance will be measured by inductively coupled plasma mass spectrometry (ICP-MS). The Gomez equations will be applied to calculate efferent arteriolar resistance, afferent arteriolar resistance, glomerular hydrostatic pressure, glomerular filtration pressure, and glomerular oncotic pressure. N-acetyl-β-D glucosaminidase (NAG) and NGAL, markers of tubular injury, will be measured by a spectrophotometric method using a commercially available kit. Routine blood and urine analyses will be performed at the Diagnostic Clinic Laboratory, University Hospital of North Norway, Tromsø.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis patients | – | Diagnostic Test: Lithium measuresNo interventions |
| Healthy controls | – | Diagnostic Test: Lithium measuresNo interventions |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients and healthy controls
Key inclusion criteria (4 listed)
- Sepsis diagnosed or suspected
- Age >18 years
- Previously healthy individuals
- Age >18 years
Key exclusion criteria (1 listed)
- Oliguria or renal impairment due to other causes than sepsis. Pregnancy or breast-feeding.
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 measuresMeasurements of lithium levels in blood and urine | Diagnostic test | Healthy controls, Sepsis patients |
Primary outcome
Renal lithium clearance
Time frame: Repeated measures between 07:00-20:00
Measurement of renal lithium clearance at 8AM, 2 PM, and 8 PM
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 12 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 4 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 12 Apr 2023. 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: Repeated measures between 07:00-20:00). 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 12 Apr 2023.