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Comparison of Two Different External Clearance Markers - Mannitol and Iohexol for Measuring Glomerular Filtration Rate

Comparison of Two Different External Clearance Markers for Measuring Glomerular Filtration Rate (GFR) - Mannitol and Iohexol, in Patients Treated in the Intensive Care Units and in Outpatients With Chronic Kidney Disease.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06238310
Acronym
GFR
Enrollment
40
Registered
2024-02-02
Start date
2023-08-01
Completion date
2025-04-01
Last updated
2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Chronic Kidney Insufficiency

Keywords

Glomerular Filtration Rate

Brief summary

GFR is the best parameter of the real kidney function. Measurements, however are time-consuming and have limited capacity. Patients treated in the intensive care units often have more than one organ-insufficiency and acute kidney injury (AKI) has an incidence of up to 70 %. GFR changes dynamically and this is one of the reasons why GFR-measurements have limited indications on the ICU. Retention of medicines or their active metabolites, however can lead to side effects, toxicity and or prolonged ICU-stay. Moreover, patients with allergy to actually standard marker, contrast material iohexol, or gravid patients are not candidate for measuring GFR with iohexol. In this prospective clinical trial two exogen marker substances will be compared, mannitol as a new marker and iohexol as a standard marker for measuring glomerular filtration rate (GFR). Patients in the intensive care units (ICU) and an outpatient group with stable chronic kidney disease (CKD) are included. The main question is, how reliable mannitol-GFR is compared to iohexol-GFR in a wide range of kidney insufficiency. GFR measurements are performed with a bolus injection technique. Patients get mannitol and iohexol bolus at time zero and blood samples are taken three times according to local protocols for iohexol clearance measurements.

Detailed description

Written inform consent from the patients or their relatives if they can not communicate. Inclusion criteria: Patients with acute or acute on chronic kidney failure (AKI, CKD), who are treated in the intensive care units because of any kind of organ insufficiency are enrolled. Stabil circulatory parameters needed with or without vasoactive drugs. Continuous intravenous administration of fluids and drugs without significant changes during the study period. Exclusion criteria: Unstable circulation and need for fluid resuscitation. Known extracellular volume expansion as ascites or peripheral edema. Intravenous paracetamol administration between or during the measurement period. Measurement with iohexol as contrast material during the previous days. Missing inform consent. Allergy to contrast material. Sample taking: at time zero and three times after the bolus injection. Timing is scheduled according to the local protocol for iohexol-GFR calculation. Samples are coded and can not identified when results are published. Outcome measures: Is mannitol clearance a reliable method for measuring GFR compared to iohexol-clearance? Comparing the two methods with Bland-Altman plots and statistical calculation for accuracy P30 and P20.

Interventions

DIAGNOSTIC_TESTComparison of two external marker substance for measuring glomerular filtration rate

Two external marker substance compares for measuring GFR.

Sponsors

Göteborg University
CollaboratorOTHER
Katalin Kiss
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients with acute or acute on chronic kidney failure (AKI, CKD) on intensive care units because of any kind of organ insufficiency. * Stabile circulatory parameters. * CKD-patients in outpatient group

Exclusion criteria

* unstable circulation with need for fluid resuscitation. * known extracellular volume expansion as ascites or peripheral edema. * Intravenous paracetamol administration between or during the measurement period. * measurement with iohexol during the previous days. * missing inform consent.

Design outcomes

Primary

MeasureTime frameDescription
Measuring GFR with two different external markers, mannitol as new and iohexol as standard marker12 weeksBland-Altman statistic is used for result comparison and Accuracy, P30 and P20 is calculated.

Countries

Sweden

Contacts

Primary ContactKatalin Kiss
katalin_kiss@icloud.com+46761285184
Backup ContactGudrun Bragadottir, MD, PhD
gudrun.bragadottir@vgregion.se+46313427453

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026