Double-Blind Placebo-Controlled CIN Trial

NCT ID: NCT02467075

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-09-30

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..

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Iopamidol 300 (Contrast)

Intervention Type: DRUG

Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan

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.

Group Type: PLACEBO_COMPARATOR

Placebo (Normal Saline)

Intervention Type: DRUG

Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan

Interventions

Iopamidol 300 (Contrast)

Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan

Intervention Type: DRUG

Placebo (Normal Saline)

Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan

Intervention Type: DRUG

Other Intervention Names

Normal saline

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radiological Society of North America

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Matthew Davenport, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Davenport, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Hospital Department of Radiology

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM 00097944

Identifier Type: -

Identifier Source: org_study_id