Description of the Evolution of Plasma and Urinary Concentrations of Iohexol in a Cirrhotic Patient Population: "Pilot Study on 9 Patients"
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change of plasma concentrations of iohexol in a population of 9 cirrhotic patients from rich kinetics.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Iohexol Inj 300 MG/ML (Drug)
结局指标
主要结局
Change of plasma concentrations of iohexol in a population of 9 cirrhotic patients from rich kinetics.
时间窗: 0 minute, 15 minute, 30 minute, 1 hour, 90 minute, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours
Plasma concentration curves for iohexol according to the time.
Change of urinary concentrations of iohexol in a population of 9 cirrhotic patients from rich kinetics.
时间窗: 0 minute, 4 hours, 8 hours, 12 hours, 24 hours
Urine concentration curves for iohexol according to the time.
次要结局
- 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)