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Feasibility of eLi12

NCT07306039 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-29

No results posted yet for this study

Summary

eLi12 represents a new method to estimate the serum-lithium (Se-Li) concentration at 12 hours after the most recent lithium dose. eLi12 is a mathematical equation that presents the clinician with an estimated 12-hour Se-Li level when the lithium blood test is not taken 12 hours after the most recent lithium dose, but e.g., after 8 or 16 hours. The eLi12 equation is based on a development study and supported by two independent proof-of-concept studies. In these studies, eLi12 estimated a Se-Li concentration that was significantly closer to the 12-hour Se-Li level compared to the actual measured Se-Li in all scenarios between 3 hours and 24 hours after the most recent lithium dose. Before eLi12 can be implemented into a clinical setting, it needs to be tested whether lithium-treated patients actually can register the time for the last lithium intake (prerequisite for eLi12) and if eLi12 can provide improvements for everyday clinical work. The objective of this study is to test 1) whether lithium-treated patients can register the time of the most recent lithium intake at the time of their lithium blood test (which is a necessary data point for the eLi12 equation), 2) the difference between eLi12 and Se-Li, 3) if eLi12 will have less variation compared to the actual measured Se-Li concentrations, 4) patient satisfaction with the eLi12 solution and self-reported symptoms, and 5) clinician satisfaction with the eLi12 solution.

Conditions

  • Bipolar Disorder (BD)

Interventions

PROCEDURE

Participants will have shown eLi12

Participants will have shown eLi12, the estimated 12-hour lithium level, in the electronic patient journal

PROCEDURE

Participants will not have shown eLi12

Participants will not have shown eLi12, the estimated 12-hour lithium level, in the electronic patient journal

Sponsors & Collaborators

  • Randers Regional Hospital

    collaborator OTHER

  • Gødstrup Hospital

    collaborator OTHER

  • Ole Köhler-Forsberg

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-03
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07306039 on ClinicalTrials.gov