Double-Blind Placebo-Controlled CIN Trial

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02467075
• Other study ID #: HUM 00097944
• Status: Terminated
• Phase: Phase 4
• First received: June 3, 2015
• Last updated: February 8, 2017
• Start date: July 2015
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This double-blinded placebo-controlled non-inferiority study will examine the incidence and significance of contrast-induced acute kidney injury following intravenous iodinated 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.

Description:

This double-blinded placebo-controlled non-inferiority study will examine the incidence and significance of contrast-induced acute kidney injury following intravenous iodinated 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 pre and three hours post-CT.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inpatients scheduled for CT scan of abdomen and/or pelvis

• Have 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 necessitates (eg, CT angiogram) or contraindicates (eg, renal stone CT) intravascular contrast

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• Iopamidol 300
Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan
• Placebo (Normal Saline)
Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan

Locations

Country	Name	City	State
United States	University of Michigan Hospital Department of Radiology	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Radiological Society of North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage II AKI by AKIN criteria	Stage II AKI by AKIN criteria comparing baseline serum creatinine with 48 hour serum creatinine	48 hours
Secondary	Secondary definitions of AKI	Other definitions of AKI, including: stage I AKI, traditional CIN definitions	48-72 hours
Secondary	Renal replacement therapy	Number of participants requiring renal replacement therapy (ie, renal transplant or dialysis) within 30 days of intervention	30 days
Secondary	Hospital length of stay	Hospital length of stay	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary	30-day readmission rate	Hospital readmission rate within 30 days of intervention	30 days
Secondary	Need for additional imaging / procedures	Number of additional percutaneous procedures and/or CT studies of the abdomen/pelvis within 30 days of intervention	30 days
Secondary	Mortality rate	30-day mortality rate	30 days