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

Purpose

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.

Condition	Intervention
Kidney Disease	Procedure: Blood work

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Comparative Investigation of Intravenously Administered Omnipaque and Isovue: Effects on Serum Creatinine Concentration in Outpatients

Resource links provided by NLM:

Drug Information available for: Iopamidol Iohexol

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

The primary outcome is the change in serum creatinine concentration from the baseline obtained immediately prior to contrast administration. [ Time Frame: 48 and 72 hours from the baseline exam ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 48 and 72 hours from the baseline exam ] [ Designated as safety issue: No ]

Enrollment:	413
Study Start Date:	October 2009
Estimated Study Completion Date:	January 2014
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Isovue Arm Subjects with a clinically scheduled CT examination will be given the contrast Isovue. The investigators of this study will determine which contrast medication subjects will receive using randomization.	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.
Experimental: Omnipaque Arm Subjects with a clinically scheduled CT examination will be given the contrast Omnipaque. The investigators of this study will determine which contrast medication subjects will receive using randomization	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.

Arms

Assigned Interventions

Experimental: Isovue Arm

Subjects with a clinically scheduled CT examination will be given the contrast Isovue. The investigators of this study will determine which contrast medication subjects will receive using randomization.

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.

Experimental: Omnipaque Arm

Subjects with a clinically scheduled CT examination will be given the contrast Omnipaque. The investigators of this study will determine which contrast medication subjects will receive using randomization

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.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734357

Locations

United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

GE Healthcare

More Information

No publications provided

Responsible Party:	Mahmoud Al-Hawary, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier:	NCT00734357 History of Changes
Other Study ID Numbers:	HUM00019769
Study First Received:	August 12, 2008
Last Updated:	February 15, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

contrast
ct
cat scan

kidney
nephrotoxicity
Computerized Emission Tomography

Additional relevant MeSH terms:

Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013