NCT06238310 Comparison of Two Different External Clearance Markers - Mannitol and Iohexol for Measuring Glomerular Filtration Rate
| NCT ID | NCT06238310 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Katalin Kiss |
| Condition | Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2025-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-08-01 with a primary completion date of 2025-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Gudrun Bragadottir, MD, PhD
STUDY DIRECTOR
Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
Frequently Asked Questions
Who can join the NCT06238310 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06238310 currently recruiting?
Yes, NCT06238310 is actively recruiting participants. Contact the research team at katalin_kiss@icloud.com for enrollment information.
Where is the NCT06238310 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT06238310 clinical trial?
NCT06238310 is sponsored by Katalin Kiss. The principal investigator is Gudrun Bragadottir, MD, PhD at Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden. The trial plans to enroll 40 participants.
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