Expired Study
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Ann Arbor, Michigan 48109


Purpose:

This double-blinded placebo-controlled non-inferiority study will examine the incidence and significance of contrast-induced acute kidney injury following intravenous iodinated contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease. Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN criteria.


Study summary:

This double-blinded placebo-controlled non-inferiority study will examine the incidence and significance of contrast-induced acute kidney injury following intravenous iodinated contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease. Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN criteria. Secondary outcome measures will include AKI by other definitions (stage I AKI, traditional CI-AKI definition), hospital length of stay, 30-day readmission rate, number of additional percutaneous interventions within 30 days, number of additional CT examinations within 30 days, and 30-day mortality rate. All subjects will receive a minimum of 1 mL/kg/hr (max: 125 mL/hr) of volume expansion for at least three hours pre and three hours post-CT.


Criteria:

Inclusion Criteria: - Inpatients scheduled for CT scan of abdomen and/or pelvis - Have had surgery in the last 4 weeks - Stable renal function (based on serum creatinine-last two lab values +/- 0.3 of each other, with most recent within 5 days of CT) - Suspected infection or fluid collection in abdomen and/or pelvis Exclusion Criteria: - Pregnant - Severe Allergy (anaphylaxis) to contrast - Dialysis in last 7 days - Received intravascular iodinated contrast in last 48 hours - CT of abdomen and pelvis in last 7 days shows no fluid collection - Prisoners - CT ordered for an indication that necessitates (eg, CT angiogram) or contraindicates (eg, renal stone CT) intravascular contrast


NCT ID:

NCT02467075


Primary Contact:

Principal Investigator
Matthew Davenport, MD
University of Michigan


Backup Contact:

N/A


Location Contact:

Ann Arbor, Michigan 48109
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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