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Endogenous Lithium Clearance in Acute Kidney Injury

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ClinicalTrials.gov Identifier: NCT05982340
Recruitment Status : Recruiting
First Posted : August 8, 2023
Last Update Posted : January 18, 2024
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway

Tracking Information
First Submitted Date July 31, 2023
First Posted Date August 8, 2023
Last Update Posted Date January 18, 2024
Actual Study Start Date August 1, 2023
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 16, 2024)		 Renal lithium clearance [ Time Frame: 2 days ]
Clearance of lithium from the body
Original Primary Outcome Measures
 (submitted: July 31, 2023)		 Lithium clearance [ Time Frame: 2 days ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endogenous Lithium Clearance in Acute Kidney Injury
Official Title Endogenous Lithium Clearance in Acute Kidney Injury
Brief 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. 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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine and blood
Sampling Method Probability Sample
Study Population Critically ill patients and healthy controls
Condition
  • Acute Kidney Injury Due to Sepsis
  • Proximal Tubule Function
  • Lithium Clearance
Intervention Diagnostic Test: Lithium clearance
Blood and urine samples
Study Groups/Cohorts
  • Group 1
    ICU patients with AKI
    Intervention: Diagnostic Test: Lithium clearance
  • Group 2
    ICU patients with normal renal function
    Intervention: Diagnostic Test: Lithium clearance
  • Group 3
    Healthy controls
    Intervention: Diagnostic Test: Lithium clearance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 31, 2023)		 30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • ICU patients diagnosed with AKI, without AKI and healthy controls

Exclusion Criteria:

-
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Lars Marius Ytrebø 90788058 lars.marius.ytrebo@unn.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT05982340
Other Study ID Numbers 03055 PVO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party University Hospital of North Norway
Original Responsible Party Same as current
Current Study Sponsor University Hospital of North Norway
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Lars MG Ytrebø, MD PhD University Hospital of North Norway
PRS Account University Hospital of North Norway
Verification Date July 2023