The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endogenous Lithium Clearance in Acute Kidney Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Acute Kidney Injury Due to Sepsis Proximal Tubule Function Lithium Clearance Diagnostic Test: Lithium clearance

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Endogenous Lithium Clearance in Acute Kidney Injury
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Group 1
ICU patients with AKI
 Diagnostic Test: Lithium clearance
Blood and urine samples
Group 2
ICU patients with normal renal function
 Diagnostic Test: Lithium clearance
Blood and urine samples
Group 3
Healthy controls
 Diagnostic Test: Lithium clearance
Blood and urine samples


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Renal lithium clearance [ Time Frame: 2 days ]
    Clearance of lithium from the body


Biospecimen Retention:   Samples Without DNA
Urine and blood

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Critically ill patients and healthy controls
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05982340


Contacts
Layout table for location contacts
Contact: Lars Marius Ytrebø 90788058 lars.marius.ytrebo@unn.no

Locations
Layout table for location information
Norway
University Hospital of North Norway Recruiting
Tromsø, Troms, Norway, 9038
Contact: Lars M Ytrebø, MD PhD    +47 90788058    lars.marius.ytrebo@unn.no   
Sub-Investigator: Kjellbjorn Jakobsen, MD         
Sponsors and Collaborators
University Hospital of North Norway
Investigators
Layout table for investigator information
Principal Investigator: Lars MG Ytrebø, MD PhD University Hospital of North Norway
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT05982340    
Other Study ID Numbers: 03055 PVO
First Posted: August 8, 2023    Key Record Dates
Last Update Posted: January 18, 2024
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
 Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs