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

January 25, 2024 updated by: Katalin Kiss

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients in the intensive care unit and outpatients with acute or chronic kidney insufficiency
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
Two external marker substance compares for measuring GFR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Katalin Kiss

Collaborators

Göteborg University

Investigators

  • Study Director: Gudrun Bragadottir, MD, PhD, Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

February 5, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mannitol GFR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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