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

Primary Purpose

Kidney Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Blood work

About this trial

This is an interventional diagnostic trial for Kidney Disease focused on measuring contrast, ct, cat scan, kidney, nephrotoxicity, Computerized Emission Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Michigan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Isovue Arm

Omnipaque Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

The primary outcome is the change in serum creatinine concentration from the baseline obtained immediately prior to contrast administration.

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.

Full Information

NCT ID

NCT00734357

First Posted

August 12, 2008

Last Updated

June 12, 2014

Sponsor

University of Michigan

Collaborators

GE Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT00734357

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

GE Healthcare

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Disease

Keywords

contrast, ct, cat scan, kidney, nephrotoxicity, Computerized Emission Tomography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

413 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Isovue Arm

Arm Type

Experimental

Arm Description

Arm Title

Omnipaque Arm

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Blood work

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Time Frame

48 and 72 hours from the baseline exam

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

University of Michigan Hospital

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

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

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