Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00478556
First received: May 24, 2007
Last updated: May 19, 2010
Last verified: May 2010
  Purpose

Patients who are scheduled by their health care provider for routine computed tomography (CT) scan will be asked to participate in this study. The primary purpose is to determine if there is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference in bowel opacification for the two agents.


Condition Intervention Phase
Healthy
Drug: Omnipaque
Drug: Gastroview
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Preferred Contrast Agent [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither.


Secondary Outcome Measures:
  • Bowel Opacification Score [ Time Frame: Collected day of study ] [ Designated as safety issue: No ]
    The bowel opacification score was calculated by adding values for stomach, duodenum, jejunum and ileum for each patient. They were averaged across two doctors who read the studies. Scores can range from 0 (no opacification) to 3 (excellent) for each segment and from 0 to 12 for bowel opacification score.


Enrollment: 300
Study Start Date: August 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Gastroview
Drug: Gastroview
Oral CT contrast
Other Name: diatrizoate meglumine and diatrizoate sodium solution USP
Experimental: 2
Omnipaque
Drug: Omnipaque
Oral CT contrast
Other Name: Iohexol

  Hide Detailed Description

Detailed Description:

Participants must be scheduled for a CT scan prior to enrollment in this study. Informed consent will be obtained from patients acceptable to be included in the study. It will be noted if there is a history of gastrointestinal surgery and if the patient is nauseated before the contrast is administered.

Patients will be randomized to receive either a standardized dilution of Gastroview or Omnipaque orally. The two agents will be prepared to have nearly equivalent iodine concentration. No flavoring agent (ie Crystal Light) will be added. The plan is to mix the agents per manufacturer recommendation as follows:

Omnipaque 350 26cc in 974 cc of water (9.0g iodine) Gastroview 25cc in 1000cc of water (9.17g iodine)

The time the patients start and stop consuming the contrast as well as the volume taken and time from first drink to start of the scan will be recorded by a blinded investigator. Patients will be asked to drink 900cc. Technical staff will report any side effects or complications observed.

After completion of the CT scan, patients will fill in a survey rating the taste of the agent on a 5 point scale, and will be asked to report any side effects. Planned rating scale is as follows:

  • 2=Dislike very much
  • 1=Dislike moderately 0=Neither like nor dislike

    • 1=Like moderately
    • 2=Like very much

A taste test between the two agents will then be administered by a blinded investigator. Patients will be given 30 cc of each agent. The order in which the agents are administered will be randomized. Patients will be asked to rate preference, if any, for either agent on a 3 point scale. Potential bias related to which agent was administered for the CT will analyzed from the data.

Planned rating scale is as follows:

  • 1- A is better 0 -no difference

    • 1- B is better

Patients will be contacted by telephone the day after the CT to assess for any delayed side effects such as diarrhea, constipation, and abdominal cramping experienced in the 24 hours following.

Bowel opacification will be rated by 2 body imagers blinded to the agent the patient received. Degree of opacification of the stomach, duodenum, jejunum, and ileum will be rated on a 4 point scale. If contrast has reached the colon, ascending, transverse, descending and sigmoid will be similarly evaluated. Four point rating scale is as follows:

0= absent opacification

  1. minimal (<25% of analyzed segments opacified)
  2. good (>25 % and < 75% of analyzed segments opacified)
  3. excellent (> 75% of analyzed segments opacified)

Description of tests/procedures to be performed. Patients will undergo contrast enhanced abdominal pelvis CT as ordered by the referring clinician. Patients will be randomized to either dilute Omnipaque or dilute Gastroview for oral contrast. Both agents will be in a concentration of 9 mg of iodine/ml, and a volume of 900 cc.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients at least 19 years of age scheduled for outpatient contrast enhanced abdominal pelvic CT at The Kirklin Clinic in Birmingham Alabama as part of clinical care with the patient's provider will be screened for eligibility.

Exclusion Criteria:

  • Not competent to give consent.
  • Pregnant.
  • Known allergy to either of the contrast agents.
  • Loss of sense of taste or smell.
  • Contraindication to oral administration such as aspiration risk.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478556

Locations
United States, Alabama
The Kirklin Clinic
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
GE Healthcare
Investigators
Principal Investigator: Michelle McNamara, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Michelle McNamara, MD, UAB Hospital
ClinicalTrials.gov Identifier: NCT00478556     History of Changes
Other Study ID Numbers: F070208011, Omnipaque vs Gastroview Oral
Study First Received: May 24, 2007
Results First Received: February 9, 2010
Last Updated: May 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
CT scan
oral contrast

Additional relevant MeSH terms:
Diatrizoate
Diatrizoate Meglumine
Urovision
Iohexol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014