Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography

Study Overview
=================
Brief Summary
-----------------
It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Detailed Description
-----------------
GEHC has decided not to provide this detail

Official Title
-----------------
GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.

Conditions
-----------------
Renal Insufficiency, Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Iodixanol 320-Arm 1
* Drug: Iopamidol 300-Arm 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a combination of diabetes mellitus (type I or II) and renal impairment who are referred for a contrast-enhanced CT examination. Exclusion Criteria: Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not permitted. Patients undergoing dialysis or kidney transplantation will not be included.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iodixanol 320-Arm 1<br>Iodixanol 320 mg I/mL | Drug: Iodixanol 320-Arm 1<br> <br> * Other names: Visipaque;|
| Active Comparator: Iopamidol 300-Arm 2<br>Iopamidol 300 mg I/mL | Drug: Iopamidol 300-Arm 2<br> <br> * Other names: Isovue;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function. | The primary endpoint was the incidence rate of CIN, defined as an intra-individual increase in serum creatinine (SCr) of greater than or equal to 44.2 µmol/L (greater than or equal to 0.5 mg/dL). Subjects with a pre-contrast (baseline) serum creatinine value greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.3 mg/dL for females or eGFR of less than or equal to 50 mL/min/1.73m squared, and a post-contrast serum creatinine value available on days 2 or 3, administered greater than or equal to100 mL or greater than or equal to 1.5 mL/kg bodyweight IMP, without presence of any major protocol violations, and without evidence of other causes inducing acute renal dysfunction. | From baseline up to 3 days post contrast administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination. | Overall Image Quality rated as Excellent, Good, Sufficient or Insufficient Poor by radiologists blinded to the contrast administration. | Within 2, 3 and 7 days post contrast administration. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iodixanol, Iopamidol, computed tomography, Patients with pre-existing renal impairment and diabetes