IV Contrast Dosing
Conditions
Keywords
IV contrast, contrast dosing
Brief summary
There are several different methods that can be used to determine the dose of iodinated contrast material for a CT scan. These include a standard fixed dose, a dose based on total body weight, a dose based on body mass index, a dose based on lean body weight, and a dose based on estimated lean body weight. The fixed dose method uses a predetermined amount of contrast material for all patients having a CT scan of the abdomen regardless of size. This is the standard procedure currently used at Duke. The other methods use the patient's weight, either the total body weight or lean body weight, to determine the amount of contrast necessary for the CT exam. For this study, the investigators will use the fixed dose, total body weight, the lean body weight, and estimated lean body weight methods. The purpose of this study is to evaluate these five methods of determining the IV contrast volume and which may be best for abdominal CT scanning.
Interventions
DRUGIsovue 370
All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
OTHERWeight calculation
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or non-lactating, non-pregnant females * 18 years or older who are able to give written informed consent
Exclusion criteria
* a chronic underlying liver disease such as cirrhosis, fatty infiltration of the liver or glycogen storage diseases * patients with a prolonged cardiac transit time such as those with a congested heart failure, a history of prior cardiac valve replacement, or restrictive/constrictive pericarditis * patients having undergone any other radiological procedure utilizing iodinated contrast with the 24 hours prior to the CT exam * patients above a certain total body weight (440 lbs.) due to limitation of the scales themselves (determined by manufacturer) * any subjects with a history of hypersensitivity to iodine-containing compounds or renal insufficiency (serum creatinine \>1.8) * subjects with implanted electronic devices (pacemakers, defibrillators, insulin pumps, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | baseline, post-dose imaging (approximately 1hr) | Operator-defined regions-of-interest (ROI) will be obtained from liver parenchyma, the portal vein and the abdominal aorta prior to contrast administration and on each slice through the liver post-contrast. Sum of all three areas reported as Summed measurement. |
Secondary
| Measure | Time frame |
|---|---|
| Difference in Volume of Contrast Used, Measured in Milliliters | baseline, post-dose imaging (approximately 1hr) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fixed Dose 50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. | 29 |
| Total Body Weight 25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation | 29 |
| Calculated Lean Body Weight 25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.
Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation | 29 |
| Measured Lean Body Weight 50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.
Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation | 27 |
| Estimated Lean Body (eLBW) Weight 25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation | 25 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Exclusion Criteria: Fatty Liver | 4 | 2 | 3 | 2 | 0 |
| Overall Study | Full dose not received | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Fixed Dose | Total Body Weight | Calculated Lean Body Weight | Measured Lean Body Weight | Estimated Lean Body (eLBW) Weight | Total |
|---|---|---|---|---|---|---|
| Age, Customized ≥18 years | 29 participants | 29 participants | 29 participants | 27 participants | 25 participants | 139 participants |
| Region of Enrollment United States | 29 participants | 29 participants | 29 participants | 27 participants | 25 participants | 139 participants |
| Sex: Female, Male Female | 9 Participants | 17 Participants | 10 Participants | 13 Participants | 12 Participants | 61 Participants |
| Sex: Female, Male Male | 20 Participants | 12 Participants | 19 Participants | 14 Participants | 13 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 26 | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 26 | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU)
Operator-defined regions-of-interest (ROI) will be obtained from liver parenchyma, the portal vein and the abdominal aorta prior to contrast administration and on each slice through the liver post-contrast. Sum of all three areas reported as Summed measurement.
Time frame: baseline, post-dose imaging (approximately 1hr)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fixed Dose | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Aorta | 145 Hounsfield units (HU) | Standard Deviation 18 |
| Fixed Dose | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Liver | 116 Hounsfield units (HU) | Standard Deviation 15 |
| Fixed Dose | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Portal Vein | 158 Hounsfield units (HU) | Standard Deviation 21 |
| Fixed Dose | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Summed Measurement | 419 Hounsfield units (HU) | Standard Deviation 50 |
| Total Body Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Portal Vein | 167 Hounsfield units (HU) | Standard Deviation 24 |
| Total Body Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Liver | 124 Hounsfield units (HU) | Standard Deviation 13 |
| Total Body Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Aorta | 152 Hounsfield units (HU) | Standard Deviation 17 |
| Total Body Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Summed Measurement | 443 Hounsfield units (HU) | Standard Deviation 51 |
| Calculated Lean Body Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Liver | 121 Hounsfield units (HU) | Standard Deviation 14 |
| Calculated Lean Body Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Summed Measurement | 433 Hounsfield units (HU) | Standard Deviation 50 |
| Calculated Lean Body Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Portal Vein | 164 Hounsfield units (HU) | Standard Deviation 24 |
| Calculated Lean Body Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Aorta | 148 Hounsfield units (HU) | Standard Deviation 18 |
| Measured Lean Body Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Liver | 120 Hounsfield units (HU) | Standard Deviation 11 |
| Measured Lean Body Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Summed Measurement | 426 Hounsfield units (HU) | Standard Deviation 33 |
| Measured Lean Body Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Aorta | 145 Hounsfield units (HU) | Standard Deviation 13 |
| Measured Lean Body Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Portal Vein | 161 Hounsfield units (HU) | Standard Deviation 17 |
| Estimated Lean Body (eLBW) Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Portal Vein | 183 Hounsfield units (HU) | Standard Deviation 30.9 |
| Estimated Lean Body (eLBW) Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Liver | 124 Hounsfield units (HU) | Standard Deviation 12.6 |
| Estimated Lean Body (eLBW) Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Summed Measurement | 461 Hounsfield units (HU) | Standard Deviation 56 |
| Estimated Lean Body (eLBW) Weight | Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) | Aorta | 153 Hounsfield units (HU) | Standard Deviation 20 |
Secondary
Difference in Volume of Contrast Used, Measured in Milliliters
Time frame: baseline, post-dose imaging (approximately 1hr)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose | Difference in Volume of Contrast Used, Measured in Milliliters | 125 Milliliters | Standard Deviation 0 |
| Total Body Weight | Difference in Volume of Contrast Used, Measured in Milliliters | 130 Milliliters | Standard Deviation 32 |
| Calculated Lean Body Weight | Difference in Volume of Contrast Used, Measured in Milliliters | 139 Milliliters | Standard Deviation 25 |
| Measured Lean Body Weight | Difference in Volume of Contrast Used, Measured in Milliliters | 135 Milliliters | Standard Deviation 28 |
| Estimated Lean Body (eLBW) Weight | Difference in Volume of Contrast Used, Measured in Milliliters | 105 Milliliters | Standard Deviation 18 |