NCT05648435

Brief Summary

Renal lithium clearance is hypothesized to be a useful indicator of renal tubular function. In this study lithium clearance will be monitored in patients with sepsis associated acute kidney injury and in healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

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

December 5, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

December 7, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

April 12, 2023

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

December 5, 2022

Last Update Submit

April 11, 2023

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Renal lithium clearance

    Measurement of renal lithium clearance at 8AM, 2 PM, and 8 PM

    Repeated measures between 07:00-20:00

Study Arms (2)

Sepsis patients

No interventions

Diagnostic Test: Lithium measures

Healthy controls

No interventions

Diagnostic Test: Lithium measures

Interventions

Lithium measuresDIAGNOSTIC_TEST

Measurements of lithium levels in blood and urine

Healthy controlsSepsis patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Intensive care patients and healthy controls

You may qualify if:

  • Sepsis diagnosed or suspected
  • Age \>18 years
  • Previously healthy individuals
  • Age \>18 years

You may not qualify if:

  • Oliguria or renal impairment due to other causes than sepsis. Pregnancy or breast-feeding.

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

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 13, 2022

Study Start

December 7, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

April 12, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)