Acute Kidney InjuryGFRNCT06238310
Comparison of Two Different External Clearance Markers - Mannitol and Iohexol for Measuring Glomerular Filtration Rate
A study testing Comparison of two external marker substance for measuring glomerular filtration rate in people with Acute Kidney Injury and Chronic Kidney Insufficiency, run by Katalin Kiss at 1 site in Sweden.
Trial 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 %. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Insufficiency
- What is being tested?
- Comparison of two external marker substance for measuring glomerular filtration rate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
SahlgrenskaUH
Gothenburg, 41345
Katalin Kiss, MD, +46761285184, katalin_kiss@icloud.com
Gudrun Bragadottir, PhD, +46313427453, gudrun.bragadottir@vgregion.se
About this study
Official title: 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.
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.
Read more
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.
Read the 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.
- Conditions
- Acute Kidney Injury, Chronic Kidney Insufficiency
- Being tested
- Comparison of two external marker substance for measuring glomerular filtration rate
- Keywords
- Glomerular Filtration Rate
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of two external marker substance for measuring glomerular filtration rateDiagnostic test
Two external marker substance compares for measuring GFR.
| Study group | Role | What they receive |
|---|---|---|
| Patients in the intensive care unit and outpatients with acute or chronic kidney insufficiency | Experimental | Measuring glomerular filtration rate (GFR) with two different marker and the same measuring protocol. Receives: Diagnostic Test: Comparison of two external marker substance for measuring glomerular filtration rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Aug 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katalin Kiss
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Sponsor-investigator, Katalin Kiss, Sahlgrenska University Hospital
- Investigators
- Gudrun Bragadottir, MD, PhD, Study director, Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238310
- Sponsor's protocol ID
- Mannitol GFR
- Acronym
- GFR
- Status last verified
- Jun 2024
- First submitted
- 16 Jan 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dhont E, Windels C, Snauwaert E, Van Der Heggen T, de Jaeger A, Dhondt L, Delanghe J, Croubels S, Walle JV, De Paepe P, De Cock PA. Reliability of glomerular filtration rate estimating formulas compared to iohexol plasma clearance in critically ill children. Eur J Pediatr. 2022 Nov;181(11):3851-3866. doi: 10.1007/s00431-022-04570-0. Epub 2022 Sep 2.
PubMed 36053381Kiss K, Molnar M, Sondergaard S, Molnar G, Ricksten SE. Mannitol clearance for the determination of glomerular filtration rate-a validation against clearance of 51 Cr-EDTA. Clin Physiol Funct Imaging. 2018 Jan;38(1):10-16. doi: 10.1111/cpf.12374. Epub 2016 Jun 3.
PubMed 27256921
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06238310
- Acronym / sponsor ID
- GFR / Mannitol GFR
- Conditions
- Acute Kidney Injury, Chronic Kidney Insufficiency
- Keywords
- Glomerular Filtration Rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Katalin KissUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in the intensive care unit and outpatients with acute or chronic kidney insufficiency | Experimental | Diagnostic Test: Comparison of two external marker substance for measuring glomerular filtration rateMeasuring glomerular filtration rate (GFR) with two different marker and the same measuring protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of two external marker substance for measuring glomerular filtration rateTwo external marker substance compares for measuring GFR. | Diagnostic test | Patients in the intensive care unit and outpatients with acute or chronic kidney insufficiency |
Primary outcome
Measuring GFR with two different external markers, mannitol as new and iohexol as standard marker
Time frame: 12 weeks
Bland-Altman statistic is used for result comparison and Accuracy, P30 and P20 is calculated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Background: PubMed 36053381Dhont E, Windels C, Snauwaert E, Van Der Heggen T, de Jaeger A, Dhondt L, Delanghe J, Croubels S, Walle JV, De Paepe P, De Cock PA. Reliability of glomerular filtration rate estimating formulas compared to iohexol plasma clearance in critically ill children. Eur J Pediatr. 2022 Nov;181(11):3851-3866. doi: 10.1007/s00431-022-04570-0. Epub 2022 Sep 2.
- Results publication: PubMed 27256921Kiss K, Molnar M, Sondergaard S, Molnar G, Ricksten SE. Mannitol clearance for the determination of glomerular filtration rate-a validation against clearance of 51 Cr-EDTA. Clin Physiol Funct Imaging. 2018 Jan;38(1):10-16. doi: 10.1111/cpf.12374. Epub 2016 Jun 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gudrun Bragadottir, MD, PhD study director
Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of two external marker substance for measuring glomerular filtration rate in people with Acute Kidney Injury and Chronic Kidney Insufficiency, run by Katalin Kiss at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katalin Kiss (+46761285184, katalin_kiss@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring GFR with two different external markers, mannitol as new and iohexol as standard marker (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06238310, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.