Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT00734357
Eligibility Criteria:
Inclusion Criteria:
* Patients 18 years of age and older
* Patients referred for a contrast-enhanced CT examination. Such contrast- enhanced CT examinations include, but are not limited to, certain examinations of the head, neck, chest, abdomen, pelvis, etc.
Exclusion Criteria:
* Patients less than age of 18 years of age
* Pregnant patients
* Patients unable to provide written informed consent
* Patients in whom there are contraindications to the administration of intravenous contrast material (as detailed in out Department of Radiology intravenous contrast material use guidelines), including renal contraindications (such as a University of Michigan laboratory record of most recent serum creatinine concentration of \>1.5 mg/dl or an estimated glomerular filtration rate (EGFR) \<60 ml/min); if no serum creatinine is available, patients will be receive contrast material based on departmental guidelines
* Patients who are undergoing therapy with agents purported to reduce the risk of CIN (such as acetylcysteine, theophylline, or intravenous hydration)
* Patients who are unable to provide the follow-up serum creatinine concentration measurements
* Patients undergoing CT examinations that utilize a higher concentration of iodine (for example, 370 mg I/ml contrast material)
* Patients who have experienced allergic-like reactions to contrast; including patients who receive corticosteroid/antihistamine premedication to reduce the risk of an acute allergic-like reaction
* Patients who do not receive the study criterion for dose of contrast material; and patients in whom a contrast extravasation of more than 5 ml occurs (so that it is not possible to determine how much contrast material the patient received as a direct intravenous injection)
* Patients participating in other investigational drug, contrast material, or device trials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00734357
Study Brief:
Protocol Section:
NCT00734357