Patients with advanced liver disease, with potential indication for liver transplantation, with or without ascites MedDRA version: 20.0 Level: PT Classification code 10019641 Term: Hepatic cirrhosis System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Trade Name: OMNIPAQUE
Pharmaceutical Form: Solution for injection
Sponsors
CHU de Limoges
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2-3-4. Moreover, patients will be over 18 years, affiliated to a social security scheme and give their informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: • Hypersensitivity to the active substance to iodinated contrast agents or any of the excipients listed in section Composition. • Antecedent of immediate major or cutaneous reaction, delayed to the injection of the iodinated contrast product (Omnipaque). • Patients with thyrotoxicosis. • Asthmatic patients. • 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 requiring anesthesia on the first day of sampling. • Patients requiring iodinated contrast injection during hospitalization and in the previous two weeks. Gadolinium injections are not contraindicated. • Patients under tutorship or curatorship or unable to give informed consent. • Patients already included in another interventional research protocol or in exclusion period. • Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Describe the evolution of plasma and urinary concentrations of iohexol in a population of 9 cirrhotic patients from rich kinetics.;Primary end point(s): Curves of plasma and urinary concentrations of iohexol as a function of time.;Timepoint(s) of evaluation of this end point: 0 minute - 15 minutes - 30 minutes - 1 hour - 1,5 hours - 2 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - 24 hours; Secondary Objective: 1. Calculate the renal clearance of iohexol. 2. Calculate the plasma clearance of iohexol. 3. Develop a pharmacokinetic model for the estimation of renal clearance from plasma clearance. 4. Evaluate the correlation between plasma clearance of iohexol obtained by the model and: A. The GFR estimated by CKD-EPI formula B. The GFR estimated by MDRD4 and MDRD6 formulas C. The GFR estimated by renal clearance of cystatine C (Uguen, Jezequel et al. 2016) 5. Determine in the model of plasmatic clearance (cf. 3rd point in the secondary outcomes) the relevant covariates. Ascites, as well as Child Pugh and MELD scores, will be included as tested covariates. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Renal clearance of iohexol obtained by non-compartmental analysis. 2. Plasma clearance of iohexol obtained by non-compartmental analysis. 3. The assessment of the performance of the model will be based on its ability to predict iohexol concentrations, expressed by the bias (%) and accuracy between urinary Predicted Plasma and Urinary and Plasma Concentrations Observed. 4. Coefficients of linear correlations and scatter plots between plasma clearance of iohexol estimated by the model and GFR calculated by different methods. Bland Altman curves will also be drawn. 5. Evaluation of covariates by multiple linear regression and point clouds (continuous covariates) or Mann Whitney and box plots (categorical covariates). Inclusion of covariates characterized by P <0.01 in the model. Search for covariates that will influence the relationship between plasma clearance and renal clearance: - grade of intensity of ascites. 2 grades: minimal (ultrasound) or moderate and bulky, - age, - weight (of the day and H24), - sex, - diuresis of 24H, - albumin, - natriuresis, - taking diuretics (nature and dose), - other drugs that can influence GFR, - biological stigmata of hepatic insufficiency or portal hypertension: bilirubin, albumin, INR, phosphatases, Child Pugh score, MELD score ;Timepoint(s) of evaluation of this end point: 0 minute - 15 minutes - 30 minutes - 1 hour - 1,5 hours - 2 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - 24 hours | — |
Countries
France
Contacts
Public ContactDirection Research and Innovation
CHU de LIMOGES
Outcome results
None listed