Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography

October 9, 2014 updated by: GE Healthcare

GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.

It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

GEHC has decided not to provide this detail

Study Type

Interventional

Enrollment (Actual)

656

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Amersham, United Kingdom, HP7 9LL
        • GE Healthcare
  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • GE Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a combination of diabetes mellitus (type I or II) and renal impairment who are referred for a contrast-enhanced CT examination.

Exclusion Criteria:

  • Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not permitted.
  • Patients undergoing dialysis or kidney transplantation will not be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Iodixanol 320-Arm 1
Iodixanol 320 mg I/mL
Drug: Iodixanol 320-Arm 1
Other Names:
  • Visipaque
Active Comparator: Iopamidol 300-Arm 2
Iopamidol 300 mg I/mL
Drug: Iopamidol 300-Arm 2
Other Names:
  • Isovue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function.
Time Frame: From baseline up to 3 days post contrast administration.

The primary endpoint was the incidence rate of CIN, defined as an intra-individual increase in serum creatinine (SCr) of greater than or equal to 44.2 µmol/L (greater than or equal to 0.5 mg/dL).

Subjects with a pre-contrast (baseline) serum creatinine value greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.3 mg/dL for females or eGFR of less than or equal to 50 mL/min/1.73m squared, and a post-contrast serum creatinine value available on days 2 or 3, administered greater than or equal to100 mL or greater than or equal to 1.5 mL/kg bodyweight IMP, without presence of any major protocol violations, and without evidence of other causes inducing acute renal dysfunction.
From baseline up to 3 days post contrast administration.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.
Time Frame: Within 2, 3 and 7 days post contrast administration.
Overall Image Quality rated as "Excellent, Good, Sufficient or Insufficient Poor" by radiologists blinded to the contrast administration.
Within 2, 3 and 7 days post contrast administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GE Healthcare

Collaborators

Quintiles, Inc.
Covance
ABX CRO
Examination Management Services Inc.
Averion International Corporation

Investigators

  • Study Director: Judith A Johnson, MS, MBA, GE Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 24, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

October 17, 2014

Last Update Submitted That Met QC Criteria

October 9, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DXV406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Iodixanol 320-Arm 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe