Status:
COMPLETED
Prevention of Serious Adverse Events Following Angiography
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
The George Institute
Conditions:
Acute Renal Failure
Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this research study is to compare the effectiveness of intravenous isotonic sodium bicarbonate with intravenous isotonic sodium chloride and oral N-acetylcysteine (NAC) with oral placeb...
Detailed Description
The intravascular administration of iodinated contrast media for diagnostic imaging is a common cause of acute kidney injury (AKI) and a leading cause of iatrogenic renal disease. Contrast-induced AKI...
Eligibility Criteria
Inclusion
- Planned elective or urgent coronary or non-coronary angiography with iodinated contrast media in which it is anticipated that there will be an interval of 3 hours between the identification of the indication for angiography and the time of the planned procedure.
- Pre-angiography eGFR \<60 ml/min/1.73 m2 with diabetes mellitus or pre-angiography eGFR \<45 ml/min/1.73 m2 with or without diabetes mellitus
- Ability to provide informed consent
Exclusion
- Stage 5 chronic kidney disease (CKD) (eGFR \<15 mL/min/1.73 m2)
- Currently receiving hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low efficiency dialysis (SLED)
- Unstable baseline serum creatinine (SCr) (if known) at the time of angiography defined by an increase in SCr of 25% over the 3 days prior to angiography
- Decompensated heart failure requiring any of the following therapies at the time of angiography:
- IV milrinone, amrinone, dobutamine, or nesiritide
- Isolated ultrafiltration therapy
- Intra-aortic balloon pump
- Emergent angiography procedures defined as an anticipated duration of \<3 hours between the identification of the indication for angiography and the time of the planned procedure.
- Receipt of intravascular iodinated contrast within the 5 days preceding angiography
- Receipt of oral or IV NAC within the 48 hours preceding angiography
- Known allergy to N-acetylcysteine (NAC)
- Known anaphylactic allergy to iodinated contrast media
- Prisoner
- Age \<18 years
- Pregnancy
- Ongoing participation in an unapproved concurrent interventional study
Key Trial Info
Start Date :
October 7 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2017
Estimated Enrollment :
5177 Patients enrolled
Trial Details
Trial ID
NCT01467466
Start Date
October 7 2013
End Date
October 17 2017
Last Update
November 5 2025
Active Locations (54)
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1
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
2
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas, United States, 72205-5484
3
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
4
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121