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

NCT ID: NCT03769597

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2019-08-28

Brief 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.

Detailed Description

Cirrhosis is often complicated by kidney failure and the prognostic value of renal function (serum creatinine) during cirrhosis is included in the MELD model. In addition, chronic kidney disease (15%) after liver transplantation is also an independent mortality factor.

The most commonly used methods to estimate GFR are based on creatinine, but in patients suffering from advanced hepatic disease, such as cirrhosis, this parameter is incorrect, due to the low creatinine production and potentially to elevated serum bilirubin and decreased albumin levels. Furthermore, ascites can interfere with serum creatinine concentration. In this condition, all creatinine-based evaluations of GFR overestimate gold standard-measured GFR. Specific eGFR equations for liver disease or new approaches for estimating GFR may be necessary.

The plasma clearance of iohexol is a recognized technique for the measurement of the glomerular filtration rate (GFR).

Conditions

Cirrhosis Renal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iohexol administration

After injecting a loading dose of 5ml of Iohexol Inj 300 MG/ML 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

Group Type: EXPERIMENTAL

Iohexol Inj 300 MG/ML

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with advanced liver disease, with potential indication for liver transplantation, with or without ascites :

• No ascites: 3 patients.
• Grade 1 (mild): ascites only detectable by ultrasound examination. 3 patients.
• Grade 2 (moderate) and Grade 3 (wide): clinically significant ascites, causing moderate symmetrical distension of the abdomen, or causing severe abdominal distension. 3 patients.
• Patients will be over 18 years, affiliated to a social security scheme and give their informed consent.

Exclusion Criteria

• Hypersensitivity to the active substance to the products of iodinated contrasts or to any of the excipients mentioned in Composition section
• History of major or cutaneous immediate reaction delayed injection of iodinated contrast medium (Omnipaque)
• Patients with thyrotoxicosis
• Asthmatic patients
• Patient with a history of dysthyroidism
• Patients with severe cardiovascular disease
• Patients with central nervous system disorders especially vascular
• Patients with pheochromocytoma
• Patients with myasthenia
• Patients with sickle cell disease
• Patients with autoimmune disease
• Patients treated with metformin
• Patients requiring anesthesia on the first day of levies
• Patients with an injection of iodine contrast during hospitalization and in both previous weeks. Gadolinium injections are not not contraindicated
• Patients under guardianship or curatorship or incapacitated give informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital

Limoges, , France

Countries

France

Other Identifiers

87RI18_0007 (DFG HEP)

Identifier Type: -

Identifier Source: org_study_id