Status:
COMPLETED
Description of the Evolution of Plasma and Urinary Concentrations of Iohexol in a Cirrhotic Patient Population
Lead Sponsor:
University Hospital, Limoges
Conditions:
Cirrhosis Renal
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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:...
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%)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03769597
Start Date
January 2 2019
End Date
August 28 2019
Last Update
September 25 2019
Active Locations (1)
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1
University Hospital
Limoges, France, 87042