Health TrialsbyHealthPanel

Fluorescent Probe for Assessment of Renal Elimination

ConditionsAugmented Renal ClearanceCritical Illness
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAaron Cook

About this trial

Accurate measures of kidney function is important for precision dosing of many medications. The current methods of determining kidney function largely hinge on the use of equations that use common laboratory values such as serum creatinine \& static variables like age \& weight. These are helpful for trending over time, but often are inaccurate during times of medical illness. Other more accurate methods of measuring kidney function include urine collection, although this is not commonly used because of various reasons that make the collection inconvenient or unreliable. The new transdermal glomerular filtration (tGFR) device permits accurate, real-time evaluation of kidney function. This novel method has not been rigorously compared with urine collection \& other methods of determining kidney function in hospitalized patients. The goal of the study is to compare tGFR with other accepted methods of determining kidney function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-65 years old

critically ill or acutely ill hospitalized patients admitted to the intensive care unit

Stable/normal renal function

Disqualifiers

Prisoners

Pregnant women

Laboratory evidence of unstable kidney function (KDIGO AKI stage 1-3--This includes subjects with Scr > 1.5x baseline)

Trial design

Design model

Single group

Treatments tested in this trial

  • Relmapirazin

    Drug

    IV push of relmapirazin (Lumitrace) prior to use of the tGFR device

  • Iohexol

    Drug

    Small IV push bolus of iohexol as a probe for renal function will be administered prior to use of the tGFR device.

  • Medibeacon tGFR monitor

    Device

    The tGFR monitor will be applied to the patient after relmapirazin bolus for measurement of GFR.

  • Urine creatinine clearance collection

    Diagnostic test

    8-hour urine creatinine clearance collection will be performed during the study period to compare to tGFR \& other renal function measures.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: MediBeacon Transdermal Glomerular Filtration Rate (GFR) MonitoringExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Transdermal Glomerular Filtration Rate (tGFR) Monitoring Accuracy

Accuracy of transdermal glomerular filtration rate (GFR) monitoring compared with measured urine creatinine clearance.

Time frame
8 Hours

Secondary outcomes

1

Relmapirazin Elimination Half-Life

Elimination half-life of Relmapirazin calculated from serial serum concentration measurements obtained over 12 hours following intravenous administration.

Time frame
12 hours
2

Iohexol Elimination Half-Life

Elimination half-life of Iohexol calculated from serial serum concentration measurements obtained over 12 hours following intravenous administration.

Time frame
12 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aaron Cook

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov
Apply now