- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05648435
Lithium Clearance in Patients With High Risk of Acute Kidney Injury
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Troms
-
Tromsø, Troms, Norway, 9038
- University Hospital of North Norway
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria sepsis associated acute kidney injury:
- Sepsis diagnosed or suspected
- Age >18 years
Inclusion Criteria healthy controls:
- Previously healthy individuals
- Age >18 years
Exclusion Criteria:
Oliguria or renal impairment due to other causes than sepsis. Pregnancy or breast-feeding.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Sepsis patients
No interventions
|
Measurements of lithium levels in blood and urine
|
Healthy controls
No interventions
|
Measurements of lithium levels in blood and urine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Renal lithium clearance
Time Frame: Repeated measures between 07:00-20:00
|
Measurement of renal lithium clearance at 8AM, 2 PM, and 8 PM
|
Repeated measures between 07:00-20:00
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Acute Kidney Injury
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Antimanic Agents
- Lithium Carbonate
Other Study ID Numbers
- REK 536547
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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