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Completed

NCT Number: NCT05648435

Lithium Clearance in Patients With High Risk of Acute Kidney Injury

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lithium measures

Diagnostic Test

Measurements of lithium levels in blood and urine

Primary outcomes

  1. Renal lithium clearance

    Time frame: Repeated measures between 07:00-20:00

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

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2022
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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