About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Comparison of two external marker substance for measuring glomerular filtration rate
Diagnostic testTwo external marker substance compares for measuring GFR.
Treatment groups
Trial outcomes
Primary outcomes
Measuring GFR with two different external markers, mannitol as new and iohexol as standard marker
Bland-Altman statistic is used for result comparison and Accuracy, P30 and P20 is calculated.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Katalin Kiss
Lead sponsor
Sahlgrenska University Hospital
Sponsor institution
Göteborg University
Collaborator