Endogenous Lithium Clearance in Acute Kidney Injury | NCT05982340

Studies
Endogenous Lithium Clearance in Acute Kidney Injury

NCT05982340

Sponsor

University Hospital of North Norway

Status

Completed

Last Update Posted

Jun 22, 2025Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Acute Kidney Injury Due to Sepsis
Proximal Tubule Function
Lithium Clearance

Interventions

Lithium clearance

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2023Actual

Primary Completion Date

May 20, 2025Actual

Completion Date

May 20, 2025Actual

First Submitted Date

Jul 31, 2023

First Submission Date that Met QC Criteria

Jul 31, 2023

First Posted Date

Aug 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2025

Last Update Posted Date

Jun 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		ICU patients with AKI	Diagnostic Test: Lithium clearance
Group 2		ICU patients with normal renal function	Diagnostic Test: Lithium clearance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lithium clearance	Diagnostic Test	Blood and urine samples	Group 1 Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Renal lithium clearance	Clearance of lithium from the body	2 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ICU patients diagnosed with AKI, without AKI and healthy controls

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Critically ill patients and healthy controls

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars MG Ytrebø, MD PhD	University Hospital of North Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of North Norway		Tromsø	Troms	9038	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41507830	Derived	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.