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NCT05648435 Clinical Trial

Lithium Clearance in Patients With High Risk of Acute Kidney Injury

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05648435
Other study ID # REK 536547
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 7, 2022
Est. completion date January 31, 2023

Study information
Verified date December 2022
Source University Hospital of North Norway
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date January 31, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Lithium measures
Measurements of lithium levels in blood and urine

Locations
Country Name City State
Norway University Hospital of North Norway Tromsø Troms

Sponsors (1)
Lead Sponsor Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

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