Clinical trial NCT02467075: Double-Blind Placebo-Controlled CIN Trial
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Kidney Injury
Keywords: CT, iodinated contrast, contrast-induced AKI, kidney injury
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Radiological Society of North America
First posted: 2015-06-09
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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..

Eligibility criteria: 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

Primary outcomes:
measure: Participants With Stage II AKI (Acute Kidney Injury)
timeFrame: 48 hours
Secondary outcomes:
measure: Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition
timeFrame: 48-72 hours
measure: Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis)
timeFrame: 30 days
measure: Hospital Length of Stay
timeFrame: Duration of hospital stay (assessed from date of randomization up to 30 days)
measure: 30-day Readmission
timeFrame: 30 days
measure: Mortality Rate - 30 Day
timeFrame: 30 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital Department of Radiology
state: Michigan
Study officials:
affiliation: University of Michigan
name: Matthew Davenport, MD
role: PRINCIPAL_INVESTIGATOR
References: