Prevention of Serious Adverse Events Following Angiography (PRESERVE)
This study is currently recruiting participants.
Verified February 2013 by Department of Veterans Affairs
Sponsor:
Collaborator:
The George Institute
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01467466
First received: October 26, 2011
Last updated: February 20, 2013
Last verified: February 2013
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Purpose
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 with oral placebo for the prevention of serious adverse outcomes following angiographic procedures in high-risk patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Renal Failure Kidney Disease Coronary Artery Disease |
Drug: IV isotonic saline Drug: IV isotonic bicarbonate Drug: N-acetylcysteine Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | CSP #578 - Prevention of Serious Adverse Outcomes Following Angiography |
Resource links provided by NLM:
MedlinePlus related topics:
Coronary Artery Disease
Drug Information available for:
Acetylcysteine
U.S. FDA Resources
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- The primary outcome will be a composite of serious, adverse, patient-centered events, including death, need for acute dialysis, or persistent decline in kidney function. [ Time Frame: Within 90 days following angiography ] [ Designated as safety issue: No ]
Death will be based on medical record and/or vital status registry documentation
Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis)
Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography.
| Estimated Enrollment: | 8680 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
IV isotonic saline and oral placebo drug capsule
|
Drug: IV isotonic saline
We will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.
Drug: Placebo
A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
|
|
Active Comparator: Arm 2
IV isotonic saline and oral N-acetylcysteine drug capsule
|
Drug: IV isotonic saline
We will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.
Drug: N-acetylcysteine
NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
Other Name: NAC
|
|
Active Comparator: Arm 3
IV isotonic bicarbonate and oral placebo drug capsule
|
Drug: IV isotonic bicarbonate
We will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.
Drug: Placebo
A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
|
|
Active Comparator: Arm 4
IV isotonic bicarbonate and oral N-acetylcysteine drug capsule
|
Drug: IV isotonic bicarbonate
We will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.
Drug: N-acetylcysteine
NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
Other Name: NAC
|
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 is associated with serious adverse outcomes including death, need for dialysis, prolonged hospitalization, and acceleration in the rate of progression of underlying chronic kidney disease. The benefit of IV isotonic bicarbonate compared to IV isotonic saline and of N-acetylcysteine for the prevention of contrast-induced AKI and associated adverse outcomes remains unclear. The purpose of this trial is to compare the effectiveness of IV isotonic sodium bicarbonate with IV isotonic sodium chloride and oral NAC with placebo for the prevention of serious adverse outcomes in 8,680 high-risk patients scheduled to undergo coronary or non-coronary angiography. Using a 2 x 2 factorial design, patients will be randomized to receive: 1) either peri-procedural IV isotonic sodium bicarbonate or peri-procedural IV isotonic saline and 2) either oral NAC or oral placebo prior to and for 5 days following the angiographic procedure. The primary study endpoint is a composite outcome comprised of death, need for acute dialysis, or persistent decline in kidney function within 90 days following the index angiogram.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- ESRD requiring chronic renal replacement therapy
- Stage 5 CKD (eGFR <15 mL/min/1.73 m2)
- Acute kidney injury requiring intermittent hemodialysis or continuous renal replacement therapy at the time of angiography
- Unstable baseline 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 7 days preceding angiography
- Receipt of oral or IV NAC within the 48 hours preceding angiography
- Known allergy to N-acetylcysteine (NAC)
- Known allergy to iodinated contrast media
- Prisoner
- Age <18 years
- Pregnancy
- Ongoing participation in a concurrent interventional study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467466
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Contacts
| Contact: James S Kaufman, MD | (212) 686-7500 ext 7470 | james.kaufman@va.gov |
| Contact: Danielle L Valley | danielle.valley@va.gov |
Hide Study LocationsLocations
| United States, Arkansas | |
| Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR | Not yet recruiting |
| Little Rock, Arkansas, United States, 72205-5484 | |
| Contact: Rajesh Sachdeva, MBBS 501-257-5795 rajesh.sachdeva@va.gov | |
| United States, California | |
| VA Palo Alto Health Care System, Palo Alto, CA | Not yet recruiting |
| Palo Alto, California, United States, 94304-1290 | |
| Contact: John Giacomini, MD 650-858-3932 john.giacomini@va.gov | |
| VA San Diego Healthcare System, San Diego, CA | Not yet recruiting |
| San Diego, California, United States, 92161 | |
| Contact: William Penny, MD 858-642-3975 william.penny@va.gov | |
| San Francisco VA Medical Center, San Francisco, CA | Not yet recruiting |
| San Francisco, California, United States, 94121 | |
| Contact: Kendrick Shunk, MD 415-750-2076 kendrick.shunk@va.gov | |
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Not yet recruiting |
| West Los Angeles, California, United States, 90073 | |
| Contact: Jessie W Currier, MD 310-268-4695 jesse.currier@va.gov | |
| United States, Florida | |
| Bay Pines VA Healthcare System, Pay Pines, FL | Not yet recruiting |
| Bay Pines, Florida, United States, 33708 | |
| Contact: Mazhar A Afaq, MD 727-398-6661 ext 5279, 4234 mazhar.afaq@va.gov | |
| North Florida/South Georgia Veterans Health System, Gainesville, FL | Not yet recruiting |
| Gainesville, Florida, United States, 32608 | |
| Contact: Anthony Bavry, MD anthony.bavry@va.gov | |
| United States, Georgia | |
| Charlie Norwood VA Medical Center, Augusta, GA | Not yet recruiting |
| Augusta, Georgia, United States, 30904 | |
| Contact: Mahendra K Mandawat, MD 706-823-3902 mahendra.mandawat@va.gov | |
| Atlanta VA Medical and Rehab Center, Decatur, GA | Not yet recruiting |
| Decatur, Georgia, United States, 30033 | |
| Contact: Kreton Mavromatis, MD 404-329-2207 kreton.mavromatis@va.gov | |
| United States, Illinois | |
| Jesse Brown VA Medical Center, Chicago, IL | Not yet recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Mladen Vidovich, MD 312-996-6730 mladen.vidovich@va.gov | |
| United States, Indiana | |
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Not yet recruiting |
| Indianapolis, Indiana, United States, 46202-2884 | |
| Contact: Islam Bolad, MD 317-988-2093 islam.bolad@va.gov | |
| United States, Massachusetts | |
| VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA | Not yet recruiting |
| West Roxbury, Massachusetts, United States, 02132 | |
| Contact: Scott Kinlay, MBBS 857-203-5550 scott.kinlay@va.gov | |
| United States, Michigan | |
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48113 | |
| Contact: Claire Duvernoy, MD 734-845-5531 claire.duvernoy@va.gov | |
| United States, Minnesota | |
| Minneapolis VA Health Care System, Minneapolis, MN | Not yet recruiting |
| Minneapolis, Minnesota, United States, 55417 | |
| Contact: Edward McFalls, MD 612-725-2000 ext 3664 edward.mcfalls@va.gov | |
| United States, Missouri | |
| Kansas City VA Medical Center, Kansas City, MO | Not yet recruiting |
| Kansas City, Missouri, United States, 64128 | |
| Contact: Deepak Parashara, MD 816-861-4700 ext 52475 deepak.parashara@va.gov | |
| St. Louis VA Medical Center John Cochran Division, St. Louis, MO | Not yet recruiting |
| St Louis, Missouri, United States, 63106 | |
| Contact: Alan R Maniet, Jr., DO 314-652-4100 ext 6329 alan.maniet@va.gov | |
| United States, New Mexico | |
| New Mexico VA Health Care System, Albuquerque, NM | Not yet recruiting |
| Albuquerque, New Mexico, United States, 87108-5153 | |
| Contact: D. Michelle Ratliff, MD 505-265-1711 ext 4494 michelle.ratliff@va.gov | |
| United States, New York | |
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | Not yet recruiting |
| New York, New York, United States, 10010 | |
| Contact: Steven Sedlis, MD 212-951-3335 steven.sedlis@va.gov | |
| United States, North Carolina | |
| Durham VA Medical Center, Durham, NC | Not yet recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Sunil Rao, MD 919-684-8111 sunil.rao@va.gov | |
| United States, Ohio | |
| Cincinnati VA Medical Center, Cincinnati, OH | Not yet recruiting |
| Cincinnati, Ohio, United States, 45220 | |
| Contact: Florence Rothenberg, MD 513-861-3100 florence.rothenberg@va.gov | |
| Louis Stokes VA Medical Center, Cleveland, OH | Not yet recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Jonathan Goldberg, MD 216-791-3800 ext 4934 jonathan.goldberg@va.gov | |
| Dayton VA Medical Center, Dayton, OH | Not yet recruiting |
| Dayton, Ohio, United States, 45428 | |
| Contact: Ajay Agarwal, MD 937-262-2113 ajay.agarwal@va.gov | |
| United States, Oklahoma | |
| Oklahoma City VA Medical Center, Oklahoma City, OK | Not yet recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Mazen Abu-Fadel, MD 405-456-5378 mazen.abu-fadel@va.gov | |
| United States, Oregon | |
| Portland VA Medical Center, Portland, OR | Not yet recruiting |
| Portland, Oregon, United States, 97201 | |
| Contact: Greg Larsen, MD 503-220-8262 ext 55632 greg.larsen@va.gov | |
| United States, Pennsylvania | |
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| Contact: Steven D Weisbord, MD MSc 412-360-3911 steven.weisbord@va.gov | |
| Contact: Paul M Palevsky (412) 688-6000 ext 815932 Paul.Palevsky@va.gov | |
| Study Chair: Steven D. Weisbord, MD MSc | |
| United States, South Carolina | |
| Ralph H. Johnson VA Medical Center, Charleston, SC | Not yet recruiting |
| Charleston, South Carolina, United States, 29401-5799 | |
| Contact: Valerian L Fernandes, MD 843-789-7594 ext 7294 valerian.fernandes@va.gov | |
| United States, Tennessee | |
| Memphis VA Medical Center, Memphis, TN | Not yet recruiting |
| Memphis, Tennessee, United States, 38104 | |
| Contact: Kodangudi B Ramanathan, MD 901-523-8990 ext 7355 kodangudi.ramanathan@va.gov | |
| United States, Texas | |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Not yet recruiting |
| Dallas, Texas, United States, 75216 | |
| Contact: Emmanouil Brilakis, MD 214-857-1547 emmanouil.brilakis@va.gov | |
| Michael E. DeBakey VA Medical Center, Houston, TX | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Hani Jneid, MD 713-794-7300 ext 7823 mohammad.jneid@va.gov | |
| South Texas Health Care System, San Antonio, TX | Not yet recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Robert J Chilton, DO 210-617-5300 robert.chilton@va.gov | |
| United States, Virginia | |
| Hunter Holmes McGuire VA Medical Center, Richmond, VA | Not yet recruiting |
| Richmond, Virginia, United States, 23249 | |
| Contact: Ion S Jovin, MD 804-675-5448 ion.jovin@va.gov | |
| Salem VA Medical Center, Salem, VA | Not yet recruiting |
| Salem, Virginia, United States, 24153 | |
| Contact: Venkata S Chilakapati, MD 540-982-2463 ext 2568 venkata.chilakapati2@va.gov | |
| United States, Washington | |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Not yet recruiting |
| Seattle, Washington, United States, 98108 | |
| Contact: Kenneth Lehmann, MD 206-764-2512 kenneth.lehmann@va.gov | |
| Australia, New South Wales | |
| Concord Hospital | Recruiting |
| Concord, New South Wales, Australia, 2139 | |
| Contact: David Brieger davidb@email.cs.nsw.gov.au | |
| Gosford Hospital | Recruiting |
| Gosford, New South Wales, Australia, 2250 | |
| Contact: Maged William mwwilliam@nsccahs.health.nsw.gov.au | |
| Nepean Hospital | Recruiting |
| Kingswood, New South Wales, Australia, 2747 | |
| Contact: Hisham Hallani Hisham.Hallani@swahs.health.nsw.gov.au | |
| St. George Hospital | Recruiting |
| Kogarah, New South Wales, Australia, 2217 | |
| Contact: Ananth Prasan ananth.prasan@sesiahs.health.nsw.gov.au | |
| Liverpool Hospital | Recruiting |
| Liverpool, New South Wales, Australia, 2170 | |
| Contact: Craig Juergens c.juergens@unsw.edu.au | |
| Royal North Shore Hospital | Recruiting |
| St. Leonards, New South Wales, Australia, 2065 | |
| Contact: Gregory Nelson gnelson@med.usyd.edu.au | |
| Australia, South Australia | |
| Flinders Medical Centre | Recruiting |
| Bedford Park, South Australia, Australia, 5042 | |
| Contact: Derek Chew derek.chew@flinders.edu.au | |
| Australia, Victoria | |
| Northern Health | Recruiting |
| Epping, Victoria, Australia, 3076 | |
| Contact: William VanGaal william.vangaal@nh.org.au | |
| Austin Health | Recruiting |
| Heidelberg, Victoria, Australia, 3084 | |
| Contact: Omar Farouque omar.farouque@austin.org.au | |
| Australia, Western Australia | |
| Fremantle Hospital | Recruiting |
| Fremantle, Western Australia, Australia, 6160 | |
| Contact: Randall Hendriks rh@coastal-cardiology.com.au | |
| Sir Charles Gairdner Hospital | Recruiting |
| Nedlands, Western Australia, Australia, 6009 | |
| Contact: Joseph Hung joseph.hung@health.wa.gov.au | |
| Royal Perth Hospital | Recruiting |
| Perth, Western Australia, Australia, 6000 | |
| Contact: Matthew Erickson exiterickson@mac.com | |
Sponsors and Collaborators
The George Institute
Investigators
| Study Chair: | Steven D. Weisbord, MD MSc | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01467466 History of Changes |
| Other Study ID Numbers: | 578, 1011387 |
| Study First Received: | October 26, 2011 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Department of Veterans Affairs:
|
renal cardiovascular kidney heart clinical trial double-blind |
multi-site trial randomized drug treatment IV solutions antioxidant |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Kidney Diseases Acute Kidney Injury Renal Insufficiency Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Urologic Diseases Acetylcysteine |
N-monoacetylcystine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on May 19, 2013