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

NCT00734357 | Completed

• 1 other identifier: HUM00019769
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Isovue Arm

EXPERIMENTAL

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

Omnipaque Arm

EXPERIMENTAL

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

Interventions

Blood work PROCEDURE

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.

Isovue Arm; Omnipaque Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• GE Healthcare: collaborator

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2012
• Last Updated: June 13, 2014

Record last verified: 2014-06

Locations

US (1)