Use of Electrical Impedence to Measure Lean Body Weight as a Determinant of the Dose of Contrast Media for Abdominal CT

NCT02170688 | Completed Phase 4 Results

• 1 other identifier: Pro00010850
• Study Type: interventional
• Target: 139
• Locations: 0 countries
• Sites: N/A

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.

Conditions

IV Contrast Dosing

Keywords

IV contrast; contrast dosing

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, post-dose imaging (approximately 1hr)

Secondary Outcomes (1)

• Difference in Volume of Contrast Used, Measured in Milliliters

  baseline, post-dose imaging (approximately 1hr)

Study Arms (5)

Fixed dose

ACTIVE COMPARATOR

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).

Drug: Isovue 370

Total body weight

ACTIVE COMPARATOR

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).

Drug: Isovue 370; Other: Weight calculation

Calculated lean body weight

ACTIVE COMPARATOR

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).

Drug: Isovue 370; Other: Weight calculation

Measured lean body weight

ACTIVE COMPARATOR

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).

Drug: Isovue 370; Other: Weight calculation

Estimated lean body (eLBW) weight

ACTIVE COMPARATOR

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).

Drug: Isovue 370; Other: Weight calculation

Interventions

Isovue 370 DRUG

All contrast media doses administered for this study are within the FDA approved dose range in the package insert.

Calculated lean body weight; Estimated lean body (eLBW) weight; Fixed dose; Measured lean body weight; Total body weight

Weight calculation OTHER

Calculated lean body weight; Estimated lean body (eLBW) weight; Measured lean body weight; Total body weight

Eligibility Criteria

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

You may qualify if:

• male or non-lactating, non-pregnant females
• years or older who are able to give written informed consent

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Interventions

Iopamidol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Lisa Ho, MD
• Organization: Duke University Medical Center

lisa.ho@duke.edu

919-684-7890

Study Officials

• Lisa Ho, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 23, 2014
• Study Start: February 1, 2004
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 7, 2015
• Results First Posted: December 12, 2014

Record last verified: 2014-12