Acute Kidney Injury
Conditions
Keywords
CT, iodinated contrast, contrast-induced AKI, kidney injury
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..
Interventions
DRUGIopamidol 300 (Contrast)
Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan
DRUGPlacebo (Normal Saline)
Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan
Sponsors
Radiological Society of North America
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Stage II AKI (Acute Kidney Injury) | 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
| Measure | Time frame | Description |
|---|---|---|
| Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition | 48-72 hours | Stage I AKI, traditional CIN definitions or other definitions of AKI (acute kidney injury) at lower levels of severity |
| Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis) | 30 days | Number of subjects that require renal (kidney) replacement therapy, such as a kidney transplant or dialysis within 30 days of study participation. |
| Hospital Length of Stay | Duration of hospital stay (assessed from date of randomization up to 30 days) | Subject's hospital length of stay in days |
| 30-day Readmission | 30 days | Number of times a subject is readmitted within 30 days of study recruitment |
| Mortality Rate - 30 Day | 30 days | Number of subjects who died within 30 days of entry into the study. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 0 |
| 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 | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Placebo (Normal Saline) | Total | Iopamidol 300 (Contrast) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 84 years | 84 years | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | — |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
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.
Time frame: 48 hours
Population: Participants with State II AKI (Acute Kidney Injury)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Iopamidol 300 (Contrast) | Participants With Stage II AKI (Acute Kidney Injury) | 0 Participants |
| Placebo (Normal Saline) | Participants With Stage II AKI (Acute Kidney Injury) | 0 Participants |
Secondary
30-day Readmission
Number of times a subject is readmitted within 30 days of study recruitment
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Normal Saline) | 30-day Readmission | 0 Number of admissions | Standard Deviation 0 |
Secondary
Hospital Length of Stay
Subject's hospital length of stay in days
Time frame: Duration of hospital stay (assessed from date of randomization up to 30 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Normal Saline) | Hospital Length of Stay | 30 days | Standard Deviation 0 |
Secondary
Mortality Rate - 30 Day
Number of subjects who died within 30 days of entry into the study.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Normal Saline) | Mortality Rate - 30 Day | 0 participants |
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.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Iopamidol 300 (Contrast) | Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis) | 0 Participants |
| Placebo (Normal Saline) | Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis) | 0 Participants |
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
Time frame: 48-72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Iopamidol 300 (Contrast) | Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition | 0 Participants |
| Placebo (Normal Saline) | Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition | 0 Participants |