Lithium Clearance in Patients With High Risk of Acute Kidney Injury

April 11, 2023 updated by: University Hospital of North Norway

Proximal Tubule Function in Septic Patients as Measured by Endogenous Lithium Clearance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lithium is almost completely reabsorbed in the proximal tubule in parallel with sodium and water. What is not reabsorbed here is assumed to be fully excreted in urine, giving a reasonably accurate measurement of sodium reabsorption in the proximal tubule. Endogenous lithium clearance will be measured by inductively coupled plasma mass spectrometry (ICP-MS). The Gomez equations will be applied to calculate efferent arteriolar resistance, afferent arteriolar resistance, glomerular hydrostatic pressure, glomerular filtration pressure, and glomerular oncotic pressure. N-acetyl-β-D glucosaminidase (NAG) and NGAL, markers of tubular injury, will be measured by a spectrophotometric method using a commercially available kit. Routine blood and urine analyses will be performed at the Diagnostic Clinic Laboratory, University Hospital of North Norway, Tromsø.

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Troms
      • Tromsø, Troms, Norway, 9038
        • University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Intensive care patients and healthy controls

Description

Inclusion criteria sepsis associated acute kidney injury:

  • Sepsis diagnosed or suspected
  • Age >18 years

Inclusion Criteria healthy controls:

  • Previously healthy individuals
  • Age >18 years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sepsis patients
No interventions
Diagnostic test: Lithium measures
Measurements of lithium levels in blood and urine
Healthy controls
No interventions
Diagnostic test: Lithium measures
Measurements of lithium levels in blood and urine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal lithium clearance
Time Frame: Repeated measures between 07:00-20:00
Measurement of renal lithium clearance at 8AM, 2 PM, and 8 PM
Repeated measures between 07:00-20:00

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2022

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

December 5, 2022

First Posted (Actual)

December 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK 536547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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