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

• Status: Completed
• Trial end date: 2019-08-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Limoges

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