Trial Outcomes & Findings for Double-Blind Placebo-Controlled CIN Trial (NCT NCT02467075)
NCT ID: NCT02467075
Last Updated: 2017-06-27
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
1 participants
Primary outcome timeframe
48 hours
Results posted on
2017-06-27
Participant Flow
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.
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
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Initial CT Scan
STARTED
|
0
|
1
|
|
Initial CT Scan
COMPLETED
|
0
|
1
|
|
Initial CT Scan
NOT COMPLETED
|
0
|
0
|
|
48 Hour Follow-up
STARTED
|
0
|
1
|
|
48 Hour Follow-up
COMPLETED
|
0
|
1
|
|
48 Hour Follow-up
NOT COMPLETED
|
0
|
0
|
|
72 Hour Follow-up
STARTED
|
0
|
1
|
|
72 Hour Follow-up
COMPLETED
|
0
|
1
|
|
72 Hour Follow-up
NOT COMPLETED
|
0
|
0
|
|
30 Day Follow-up
STARTED
|
0
|
1
|
|
30 Day Follow-up
COMPLETED
|
0
|
1
|
|
30 Day Follow-up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Double-Blind Placebo-Controlled CIN Trial
Baseline characteristics by cohort
| Measure |
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
|
Placebo (Normal Saline)
n=1 Participants
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
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
—
|
84 years
n=7 Participants
|
84 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Participants with State 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.
Outcome measures
| Measure |
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
|
Placebo (Normal Saline)
n=1 Participants
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
|
|---|---|---|
|
Participants With Stage II AKI (Acute Kidney Injury)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 48-72 hoursStage I AKI, traditional CIN definitions or other definitions of AKI (acute kidney injury) at lower levels of severity
Outcome measures
| Measure |
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
|
Placebo (Normal Saline)
n=1 Participants
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
|
|---|---|---|
|
Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysNumber of subjects that require renal (kidney) replacement therapy, such as a kidney transplant or dialysis within 30 days of study participation.
Outcome measures
| Measure |
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
|
Placebo (Normal Saline)
n=1 Participants
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
|
|---|---|---|
|
Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Duration of hospital stay (assessed from date of randomization up to 30 days)Subject's hospital length of stay in days
Outcome measures
| Measure |
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
|
Placebo (Normal Saline)
n=1 days
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
|
|---|---|---|
|
Hospital Length of Stay
|
—
|
30 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 30 daysNumber of times a subject is readmitted within 30 days of study recruitment
Outcome measures
| Measure |
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
|
Placebo (Normal Saline)
n=1 Participants
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
|
|---|---|---|
|
30-day Readmission
|
—
|
0 Number of admissions
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 30 daysNumber of subjects who died within 30 days of entry into the study.
Outcome measures
| Measure |
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
|
Placebo (Normal Saline)
n=1 Participants
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
|
|---|---|---|
|
Mortality Rate - 30 Day
|
—
|
0 participants
|
Adverse Events
Iopamidol 300 (Contrast)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Normal Saline)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Matthew Davenport, MD
University of Michigan, Department of Radiology
Phone: 734-232-2095
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place