Double-Blind Placebo-Controlled CIN Trial

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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: Iopamidol 300 (Contrast); Drug: Placebo (Normal Saline)

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..

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital Department of Radiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Iopamidol 300 (Contrast); Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan
Placebo Comparator: 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.	Drug: Placebo (Normal Saline); Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan; Other Names: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Stage II AKI (Acute Kidney Injury)	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.	48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Radiological Society of North America
• Investigators: Principal Investigator: Matthew Davenport, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 9, 2015

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: CT, iodinated contrast, contrast-induced AKI, kidney injury
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: HUM 00097944

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes