Overview

This trial is active, not recruiting.

Condition acute kidney injury
Treatments iopamidol 300, placebo (normal saline)
Phase phase 4
Sponsor University of Michigan
Collaborator Radiological Society of North America
Start date July 2015
End date March 2017
Trial size 1 participant
Trial identifier NCT02467075, HUM 00097944

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Arm
(Active Comparator)
Subjects scheduled for a standard of care CT will be randomized to receive weight-based low-osmolality iodinated contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.
iopamidol 300
Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan
(Placebo Comparator)
Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.
placebo (normal saline) Normal saline
Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan

Primary Outcomes

Measure
Stage II AKI by AKIN criteria
time frame: 48 hours

Secondary Outcomes

Measure
Secondary definitions of AKI
time frame: 48-72 hours
Renal replacement therapy
time frame: 30 days
Hospital length of stay
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
30-day readmission rate
time frame: 30 days
Need for additional imaging / procedures
time frame: 30 days
Mortality rate
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase IV Randomized Double-Blinded Placebo-Controlled Noninferiority Study of the Effect of Intravenous Low-Osmolality Iodinated Contrast Material On Renal Function in Postoperative Adults With Stage IIIb or Stage IV Chronic Kidney Disease
Principal investigator Matthew Davenport, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Michigan.