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

NCT06238310 | Recruiting

• 1 other identifier: Mannitol GFR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Chronic Kidney Insufficiency

Keywords

Glomerular Filtration Rate

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (1)

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.

Diagnostic Test: Comparison of two external marker substance for measuring glomerular filtration rate

Interventions

Comparison of two external marker substance for measuring glomerular filtration rate DIAGNOSTIC_TEST

Two external marker substance compares for measuring GFR.

Patients in the intensive care unit and outpatients with acute or chronic kidney insufficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Katalin Kiss: lead
• Göteborg University: collaborator

Study Sites (1)

SahlgrenskaUH

Gothenburg, 41345, Sweden

RECRUITING

Related Publications (2)

• 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.

  PMID: 36053381 BACKGROUND

• Kiss 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.

  PMID: 27256921 RESULT

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gudrun Bragadottir, MD, PhD

  Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden

  STUDY DIRECTOR

Central Study Contacts

Katalin Kiss

CONTACT

+46761285184; katalin_kiss@icloud.com

Gudrun Bragadottir, MD, PhD

CONTACT

+46313427453; gudrun.bragadottir@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: consultant anesthesiologist

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 2, 2024
• Study Start: August 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: April 1, 2025
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)