Patient Comfort and Safety
Conditions
Keywords
Safety
Brief summary
The purpose of this study is to evaluate and compare overall patient comfort profile between the Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing Contrast-Enhanced Computed Tomographic (CECT) imaging of the abdomen/pelvis.
Interventions
Sponsors
i3 Statprobe
GE Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is over 18 years old. * Subjects are referred to undergo a CECT imaging of the abdomen/pelvis as part of their routine clinical care.
Exclusion criteria
* The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM. * The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period. * The subject is pregnant. * The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure. * The subject manifests thyrotoxicosis or is on dialysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Within 10 minutes post contrast administration | Number of subjects experiencing any moderate (score of 4 - 7) to severe (score 8 - 10) discomfort for cold or heat or pain between Iodixanol and Iopamidol. |
| Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Within 10 minutes post contrast administration. | Number of subjects experiencing moderate (score of 4 -7) to severe (score of 8 - 10) discomfort for cold, heat or pain between Iodixanol and Iopamidol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Ten minutes post contrast administration. | Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration. |
Countries
United States
Participant flow
Recruitment details
A total of 304 subjects were enrolled in this study, however, 5 subjects did not receive contrast media due to administrative and /or technical reason leaving 299 subjects included in the analysis.
Pre-assignment details
A total of 304 subjects were enrolled in this study, however, 5 subjects did not receive contrast media due to administrative and /or technical reason leaving 299 subjects included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1-Iodixanol | 151 |
| Arm 2-Iopamidol | 148 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient received no contrast media | 3 | 4 |
Baseline characteristics
| Characteristic | Arm 1-Iodixanol | Arm 2-Iopamidol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 60 Participants | 57 Participants | 117 Participants |
| Age, Categorical Between 18 and 65 years | 91 Participants | 91 Participants | 182 Participants |
| Age Continuous | 57.8 years STANDARD_DEVIATION 15.23 | 58.5 years STANDARD_DEVIATION 15.02 | 58.1 years STANDARD_DEVIATION 15.1 |
| Region of Enrollment Germany | 45 participants | 43 participants | 88 participants |
| Region of Enrollment Spain | 35 participants | 35 participants | 70 participants |
| Region of Enrollment United Kingdom | 6 participants | 8 participants | 14 participants |
| Region of Enrollment United States | 65 participants | 62 participants | 127 participants |
| Sex: Female, Male Female | 68 Participants | 80 Participants | 148 Participants |
| Sex: Female, Male Male | 83 Participants | 68 Participants | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 121 / 151 | 134 / 148 |
| serious Total, serious adverse events | 0 / 151 | 1 / 148 |
Outcome results
Primary
Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Number of subjects experiencing moderate (score of 4 -7) to severe (score of 8 - 10) discomfort for cold, heat or pain between Iodixanol and Iopamidol.
Time frame: Within 10 minutes post contrast administration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1-Iodixanol (Visipaque) | Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Discomfort of Heat | 45 Number of Subjects with discomfort |
| Arm 1-Iodixanol (Visipaque) | Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Discomfort of Pain | 5 Number of Subjects with discomfort |
| Arm 1-Iodixanol (Visipaque) | Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Discomfort of Cold | 5 Number of Subjects with discomfort |
| Arm 2-Iopamidol (Isovue) | Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Discomfort of Cold | 11 Number of Subjects with discomfort |
| Arm 2-Iopamidol (Isovue) | Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Discomfort of Heat | 94 Number of Subjects with discomfort |
| Arm 2-Iopamidol (Isovue) | Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Discomfort of Pain | 3 Number of Subjects with discomfort |
Primary
Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Number of subjects experiencing any moderate (score of 4 - 7) to severe (score 8 - 10) discomfort for cold or heat or pain between Iodixanol and Iopamidol.
Time frame: Within 10 minutes post contrast administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1-Iodixanol (Visipaque) | Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | 53 Number of Subjects with discomfort |
| Arm 2-Iopamidol (Isovue) | Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | 99 Number of Subjects with discomfort |
Secondary
Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.
Time frame: Ten minutes post contrast administration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1-Iodixanol (Visipaque) | Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Image Quality was Excellent | 144 Number of subject images |
| Arm 1-Iodixanol (Visipaque) | Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Image Quality was Adequate | 7 Number of subject images |
| Arm 1-Iodixanol (Visipaque) | Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Image Quality was Poor | 0 Number of subject images |
| Arm 2-Iopamidol (Isovue) | Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Image Quality was Excellent | 133 Number of subject images |
| Arm 2-Iopamidol (Isovue) | Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Image Quality was Adequate | 14 Number of subject images |
| Arm 2-Iopamidol (Isovue) | Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Image Quality was Poor | 1 Number of subject images |