Prevention of Serious Adverse Events Following Angiography
PRESERVE
CSP #578 - Prevention of Serious Adverse Events Following Angiography (PRESERVE)
2 other identifiers
interventional
5,177
4 countries
54
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 placebo for the prevention of serious adverse outcomes following angiographic procedures in high-risk patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2013
Typical duration for phase_3
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2011
CompletedFirst Posted
Study publicly available on registry
November 8, 2011
CompletedStudy Start
First participant enrolled
October 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2017
CompletedResults Posted
Study results publicly available
November 9, 2018
CompletedNovember 5, 2025
October 1, 2025
4 years
October 26, 2011
October 2, 2018
October 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride.
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.
Within 90 days following angiography
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo.
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.
Within 90 days following angiography
Study Arms (4)
Saline & oral placebo
ACTIVE COMPARATORIV isotonic saline and oral placebo drug capsule
Saline & oral N-acetylcysteine
ACTIVE COMPARATORIV isotonic saline and oral N-acetylcysteine drug capsule
Bicarbonate & oral placebo
ACTIVE COMPARATORIV isotonic bicarbonate and oral placebo drug capsule
Bicarbonate & oral N-acetylcysteine
ACTIVE COMPARATORIV isotonic bicarbonate and oral N-acetylcysteine drug capsule
Interventions
The investigators 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.
The investigators 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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- The George Institutecollaborator
Study Sites (54)
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, 85723, United States
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas, 72205-5484, United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290, United States
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121, United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073, United States
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, 33708, United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608, United States
Charlie Norwood VA Medical Center, Augusta, GA
Augusta, Georgia, 30904, United States
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033, United States
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612, United States
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884, United States
VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA
West Roxbury, Massachusetts, 02132, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48113, United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417, United States
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, 64128, United States
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, 63106, United States
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153, United States
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215, United States
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010, United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705, United States
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220, United States
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106, United States
Dayton VA Medical Center, Dayton, OH
Dayton, Ohio, 45428, United States
Oklahoma City VA Medical Center, Oklahoma City, OK
Oklahoma City, Oklahoma, 73104, United States
Portland VA Medical Center, Portland, OR
Portland, Oregon, 97201, United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240, United States
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799, United States
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, 38104, United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216, United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030, United States
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148, United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249, United States
Salem VA Medical Center, Salem, VA
Salem, Virginia, 24153, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108, United States
Canberra Hospital
Canberra, Australian Capital Territory, 2606, Australia
Concord Hospital
Concord, New South Wales, 2139, Australia
Gosford Hospital
Gosford, New South Wales, 2250, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
St. George Hospital
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Northern Health
Epping, Victoria, 3076, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Fremantle Hospital
Fremantle, Western Australia, 6160, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
University of Malaya Medical Center
Kuala Lumpur, Kuala Lumpur, 50603, Malaysia
Penang Hospital
George Town, Pulau Pinang, 10990, Malaysia
Hospital Serdang
Sepang, Selangor, 43300, Malaysia
Auckland City Hospital
Auckland, Auckland, 1142, New Zealand
Taranaki Base Hospital
Westown, New Plymouth, 4310, New Zealand
Wellington Hospital
Newtown, Wellington Region, 1142, New Zealand
Related Publications (1)
Weisbord SD, Gallagher M, Jneid H, Garcia S, Cass A, Thwin SS, Conner TA, Chertow GM, Bhatt DL, Shunk K, Parikh CR, McFalls EO, Brophy M, Ferguson R, Wu H, Androsenko M, Myles J, Kaufman J, Palevsky PM; PRESERVE Trial Group. Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine. N Engl J Med. 2018 Feb 15;378(7):603-614. doi: 10.1056/NEJMoa1710933. Epub 2017 Nov 12.
PMID: 29130810DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher Donnelly, Chief of Data Management
- Organization
- MAVERIC, VA Boston
Study Officials
- STUDY CHAIR
Steven D. Weisbord, MD MSc
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2011
First Posted
November 8, 2011
Study Start
October 7, 2013
Primary Completion
September 29, 2017
Study Completion
October 17, 2017
Last Updated
November 5, 2025
Results First Posted
November 9, 2018
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share