Double-Blind Placebo-Controlled CIN Trial

Phase 4

Terminated

Brief Summary: This double-blinded placebo-controlled study will examine the incidence and significance of contrast-induced acute kidney injury following IV iodine-based 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 (Acute Kidney Injury Network) criteria.

Detailed Description: This double-blinded placebo-controlled non-inferiority study will examine the incidence and significance of contrast-induced acute kidney injury following intravenous iodine-based 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 before and after the CT..

Recruitment & Eligibility

Inclusion Criteria

Inpatients scheduled for CT scan of abdomen and/or pelvis
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 requires (eg, CT angiogram) or contraindicates (eg, renal stone CT) the administration of intravascular contrast

Arm && Interventions

Group	Intervention	Description
Iopamidol 300 (Contrast)	Iopamidol 300 (Contrast)	Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast 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)	Placebo (Normal Saline)	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.

Primary Outcome Measures

Name	Time	Method
Participants With Stage II AKI (Acute Kidney Injury)	48 hours	Participants who had Stage II AKI. This is measured by comparing an initial blood creatinine level with the level at 48 hours. Creatine is a chemical waste product that passes through the kidneys. Creatinine levels reflect how well the kidneys are working.

Secondary Outcome Measures

Name	Time	Method
Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition	48-72 hours	Stage I AKI, traditional CIN definitions or other definitions of AKI (acute kidney injury) at lower levels of severity
Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis)	30 days	Number of subjects that require renal (kidney) replacement therapy, such as a kidney transplant or dialysis within 30 days of study participation.
Hospital Length of Stay	Duration of hospital stay (assessed from date of randomization up to 30 days)	Subject's hospital length of stay in days
30-day Readmission	30 days	Number of times a subject is readmitted within 30 days of study recruitment
Mortality Rate - 30 Day	30 days	Number of subjects who died within 30 days of entry into the study.

Locations (1): University of Michigan Hospital Department of Radiology
🇺🇸
Ann Arbor, Michigan, United States