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

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Mahmoud Al-Hawary, University of Michigan
ClinicalTrials.gov Identifier:
NCT00734357
First received: August 12, 2008
Last updated: June 12, 2014
Last verified: June 2014

August 12, 2008
June 12, 2014
October 2009
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00734357 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Comparative Investigation of Intravenously Administered Omnipaque and Isovue: Effects on Serum Creatinine Concentration in Outpatients
Comparative Investigation of Intravenously Administered Omnipaque and Isovue: Effects on Serum Creatinine Concentration in Outpatients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Kidney Disease
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: 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.
    Intervention: Procedure: Blood work
  • 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
    Intervention: Procedure: Blood work
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
413
October 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00734357
HUM00019769
Not Provided
Mahmoud Al-Hawary, University of Michigan
University of Michigan
GE Healthcare
Not Provided
University of Michigan
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP