Double-Blind Placebo-Controlled CIN Trial

• ClinicalTrials.gov Identifier: NCT02467075
• Recruitment Status: Terminated
• First Posted: June 9, 2015
• Results First Posted: June 27, 2017
• Last Update Posted: June 27, 2017
• Sponsor: University of Michigan
• Collaborator: Radiological Society of North America
• Information provided by (Responsible Party): Matthew Davenport, MD, University of Michigan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Kidney Injury	Drug: Iopamidol 300 (Contrast); Drug: Placebo (Normal Saline)	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• 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
• Actual Study Start Date: July 2015
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

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 Name: Normal saline

Outcome Measures

Primary Outcome Measures :

1. Participants With Stage II AKI (Acute Kidney Injury) [ Time Frame: 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 :

1. Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition [ Time Frame: 48-72 hours ]
   Stage I AKI, traditional CIN definitions or other definitions of AKI (acute kidney injury) at lower levels of severity
2. Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis) [ Time Frame: 30 days ]
   Number of subjects that require renal (kidney) replacement therapy, such as a kidney transplant or dialysis within 30 days of study participation.
3. Hospital Length of Stay [ Time Frame: Duration of hospital stay (assessed from date of randomization up to 30 days) ]
   Subject's hospital length of stay in days
4. 30-day Readmission [ Time Frame: 30 days ]
   Number of times a subject is readmitted within 30 days of study recruitment
5. Mortality Rate - 30 Day [ Time Frame: 30 days ]
   Number of subjects who died within 30 days of entry into the study.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Michigan

University of Michigan Hospital Department of Radiology

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Radiological Society of North America

Investigators

• Principal Investigator: Matthew Davenport, MD; University of Michigan

More Information

• Responsible Party: Matthew Davenport, MD, Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT02467075
• Other Study ID Numbers: HUM 00097944
• First Posted: June 9, 2015
• Results First Posted: June 27, 2017
• Last Update Posted: June 27, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Matthew Davenport, MD, University of Michigan:

CT, iodinated contrast, contrast-induced AKI, kidney injury

Additional relevant MeSH terms:

Acute Kidney Injury; Renal Insufficiency; Kidney Diseases; Urologic Diseases