Comparative Investigation of Intravenously Administered Omnipaque and Isovue: Effects on Serum Creatinine Concentration in Outpatients

Kidney Disease Clinical Trial

Official title:

Comparative Investigation of Intravenously Administered Omnipaque and Isovue: Effects on Serum Creatinine Concentration in Outpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734357
• Other study ID #: HUM00019769
• Status: Completed
• Phase: N/A
• First received: August 12, 2008
• Last updated: June 12, 2014
• Start date: October 2009
• Est. completion date: October 2012

Study information

• Verified date: June 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if one CT contrast agent (medication injected into a vein; used in CT examinations to help produce clearer images) is safer to use than another. This study will compare the safety of two widely-used, U.S. FDA approved contrast agents, Isovue and Omnipaque. The investigators hypothesize that there is no significant difference in the rates of contrast-induced nephrotoxicity (CIN) between these agents when the overall population consists of low-risk patients.

Description:

For patients without known kidney disease, it is exceptionally rare for the administration of CT contrast agents to injure the kidneys, and those rare injuries that do occur are almost always temporary (a week or two) and heal. Indeed, significant injuries are so rare that the kidney function in patients is not routinely checked after they receive CT contrast agents. There are many brands of contrast media in common use across the United States, and it has been thought in the past that all are similarly low in risk. The purpose of this study is to examine whether two different contrast materials might differ in their risk to the kidneys. We will perform a direct comparison of Omnipaque-300 (iohexol, 300 mg I/ml) and Isovue-300 (Iopamidol, 300 mg I/ml) low osmolality contrast agents to determine their relative CIN rates (as measured by serum creatinine concentration) in low-risk patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 18 years of age and older

• Patients referred for a contrast-enhanced CT examination. Such contrast- enhanced CT examinations include, but are not limited to, certain examinations of the head, neck, chest, abdomen, pelvis, etc.

Exclusion Criteria:

• Patients less than age of 18 years of age

• Pregnant patients

• Patients unable to provide written informed consent

• Patients in whom there are contraindications to the administration of intravenous contrast material (as detailed in out Department of Radiology intravenous contrast material use guidelines), including renal contraindications (such as a University of Michigan laboratory record of most recent serum creatinine concentration of >1.5 mg/dl or an estimated glomerular filtration rate (EGFR) <60 ml/min); if no serum creatinine is available, patients will be receive contrast material based on departmental guidelines

• Patients who are undergoing therapy with agents purported to reduce the risk of CIN (such as acetylcysteine, theophylline, or intravenous hydration)

• Patients who are unable to provide the follow-up serum creatinine concentration measurements

• Patients undergoing CT examinations that utilize a higher concentration of iodine (for example, 370 mg I/ml contrast material)

• Patients who have experienced allergic-like reactions to contrast; including patients who receive corticosteroid/antihistamine premedication to reduce the risk of an acute allergic-like reaction

• Patients who do not receive the study criterion for dose of contrast material; and patients in whom a contrast extravasation of more than 5 ml occurs (so that it is not possible to determine how much contrast material the patient received as a direct intravenous injection)

• Patients participating in other investigational drug, contrast material, or device trials

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases

Intervention

Procedure:
• Blood work
Prior to having the clinically scheduled CT examination the subject will have blood work drawn. This blood work will give the investigators a baseline value of the basic kidney function of the subject. They will then have blood work done again at 2 days and again at 3 days following the CT examination. Some patients, based on their blood work obtained at 2 and 3 days after the CT examination, will be asked to have blood work performed at 7 days after their CT examination.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the change in serum creatinine concentration from the baseline obtained immediately prior to contrast administration.		48 and 72 hours from the baseline exam	No
Secondary	We will also identify the number of patients in each group who develop CIN. Two separate CIN definitions will be utilized, including a rise in serum creatinine of 0.5 mg/dl from baseline and a rise in serum creatinine of 25% or greater from baseline.		48 and 72 hours from the baseline exam	No