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Description of the Evolution of Plasma and Urinary Concentrations of Iohexol in a Cirrhotic Patient Population

NCT03769597 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-09-25

No results posted yet for this study

Summary

Background: It is important to accurately assess the glomerular filtration rate (GFR) of patients with liver diseases, particularly cirrhosis, to deliver care and adjust the drugs' posology.

Purpose: The frequency of chronic renal failure is underestimated in patients with advanced liver disease and the difficulty to assess kidney failure justifies the investigator's study, which aims to describe, by means of a population pharmacokinetic model, the evolution of plasma and urinary concentrations of iohexol, an effective non-ionic, water-soluble contrast agent which is used in radiographic procedures, in cirrhotic patients.

Conditions

  • Cirrhosis Renal

Interventions

DRUG

Iohexol Inj 300 MG/ML

After injecting a loading dose of 5ml of iohexol bolus, blood samples will be taken at given times for 24 hours. The urinary samples will be taken at each urination, with measurement of the exact volume and times

Sponsors & Collaborators

  • University Hospital, Limoges

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2019-08-28
Completion
2019-08-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03769597 on ClinicalTrials.gov