Double-Blind Placebo-Controlled CIN Trial

Study Overview
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Brief Summary
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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
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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..

Official Title
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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

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Drug: Iopamidol 300 (Contrast)
* Drug: Placebo (Normal Saline)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iopamidol 300 (Contrast)<br>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)<br>* Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan<br>|
| Placebo Comparator: Placebo (Normal Saline)<br>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)<br>* Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan<br>* Other names: Normal saline;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT, iodinated contrast, contrast-induced AKI, kidney injury