NCT05982340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

June 22, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

July 31, 2023

Last Update Submit

June 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Renal lithium clearance

    Clearance of lithium from the body

    2 days

Study Arms (2)

Group 1

ICU patients with AKI

Diagnostic Test: Lithium clearance

Group 2

ICU patients with normal renal function

Diagnostic Test: Lithium clearance

Interventions

Lithium clearanceDIAGNOSTIC_TEST

Blood and urine samples

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients and healthy controls

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and blood

Study Officials

  • Lars MG Ytrebø, MD PhD

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 8, 2023

Study Start

August 1, 2023

Primary Completion

May 20, 2025

Study Completion

May 20, 2025

Last Updated

June 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations