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

NCT03769597 | Completed Phase 4

• 1 other identifier: 87RI18_0007 (DFG HEP)
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis Renal

Keywords

Cirrhosis Renal; GFR; renal function; Bayesian model; plasma clearance; iohexol

Outcome Measures

Primary Outcomes (2)

• Change of plasma concentrations of iohexol in a population of 9 cirrhotic patients from rich kinetics.

  Plasma concentration curves for iohexol according to the time.

  0 minute, 15 minute, 30 minute, 1 hour, 90 minute, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours

• Change of urinary concentrations of iohexol in a population of 9 cirrhotic patients from rich kinetics.

  Urine concentration curves for iohexol according to the time.

  0 minute, 4 hours, 8 hours, 12 hours, 24 hours

Secondary Outcomes (5)

• Calculate the renal clearance of iohexol.

  0 minute, 15 minute, 30 minute, 1 hour, 90 minute, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours

• Calculate the plasma clearance of iohexol.

  0 minute, 15 minutes, 30 minutes, 1 hour, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours

• Develop a pharmacokinetic model for the estimation of renal clearance from plasma clearance.

  0 minute, 15 minutes, 30 minutes, 1 hour, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hrs

• Evaluate the correlation between plasma clearance of iohexol obtained by the model and The GFR estimated by (CKD-EPI formula B, MDRD4 and MDRD6 formulas C, renal clearance of cystatine C)

  0 minute, 24 hours

• Determine in the model of plasmatic clearance the relevant covariates.

  0 minute, 24 hours

Study Arms (1)

Iohexol administration

EXPERIMENTAL

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

Drug: Iohexol Inj 300 MG/ML

Interventions

Iohexol Inj 300 MG/ML 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

Iohexol administration

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

University Hospital

Limoges, 87042, France

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 7, 2018
• Study Start: January 2, 2019
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: September 25, 2019

Record last verified: 2018-08

Locations

FR (1)