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Insufficient number of subjects could be enrolled.
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| Name | Class |
|---|---|
| Radiological Society of North America | OTHER |
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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.
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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iopamidol 300 (Contrast) | Active Comparator | 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. |
|
| Placebo (Normal Saline) | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iopamidol 300 (Contrast) | Drug | Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Davenport, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital Department of Radiology | Ann Arbor | Michigan | 48109 | United States |
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Patients had to be scheduled for a CT that did not have a) requirement for the CT scan to be performed with contrast agent or b) a contraindication against having the CT scan with contrast agent
Subjects were recruited from inpatients at a tertiary medical center who were scheduled to have a clinical CT for a suspected infection. Subjects had to have a previous diagnosis of Chronic Kidney Disease (CKD) Stage II or IIB and stable creatinine levels. Their physician had to agree to their participation in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 3 hours before and 3 hours after the CT. The function of the fluids is to minimize the effect of the contrast on their creatinine level. Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan |
| FG001 | Placebo (Normal Saline) | Subjects scheduled for a clinical CT will be randomized to receive 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 3 hours before and 3 hours after the CT. The fluids are given to placebo patients in order to minimize any differences in treatment between the treatment and placebo groups. Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial CT Scan |
| |||||||||||||
| 48 Hour Follow-up |
| |||||||||||||
| 72 Hour Follow-up |
| |||||||||||||
| 30 Day Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants with State II AKI (Acute Kidney Injury) | Posted | Count of Participants | Participants | 48 hours |
|
Subjects were followed for 30 days
The same definitions of adverse events and serious adverse events has been used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iopamidol 300 (Contrast) | Subjects scheduled for a clinical CT were 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 3 hours before and 3 hours after the CT. Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan |
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The decision to terminate the study due to low accrual potential was made in February 2016, but last data collection from the 1 subject was in September 2015.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Davenport, MD | University of Michigan, Department of Radiology | 734-232-2095 | matdaven@med.umich.edu |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D003287 | Contrast Media |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D064907 | Diagnostic Uses of Chemicals |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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| Placebo (Normal Saline) | Drug | Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan |
|
|
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 |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 48-72 hours |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Hospital Length of Stay | Subject's hospital length of stay in days | Posted | Mean | Standard Deviation | days | Duration of hospital stay (assessed from date of randomization up to 30 days) | days | days |
|
|
|
| Secondary | 30-day Readmission | Number of times a subject is readmitted within 30 days of study recruitment | Posted | Mean | Standard Deviation | Number of admissions | 30 days |
|
|
|
| Secondary | Mortality Rate - 30 Day | Number of subjects who died within 30 days of entry into the study. | Posted | Number | participants | 30 days |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo (Normal Saline) | Subjects scheduled for a clinical CT were 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 3 hours before and 3 hours after the CT. Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan | 0 | 1 | 0 | 1 | 0 | 1 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |