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Prevention of Serious Adverse Events Following Angiography (PRESERVE)

Primary Purpose

Acute Renal Failure, Kidney Disease, Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IV isotonic saline
IV isotonic bicarbonate
N-acetylcysteine
Placebo
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Renal Failure focused on measuring renal, cardiovascular, kidney, heart, clinical trial, double-blind, multi-site trial, randomized, drug treatment, IV solutions, antioxidant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Southern Arizona VA Health Care System, Tucson
  • Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
  • VA Palo Alto Health Care System, Palo Alto, CA
  • San Francisco VA Medical Center, San Francisco, CA
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • Bay Pines VA Healthcare System, Pay Pines, FL
  • North Florida/South Georgia Veterans Health System, Gainesville, FL
  • Charlie Norwood VA Medical Center, Augusta, GA
  • Atlanta VA Medical and Rehab Center, Decatur, GA
  • Jesse Brown VA Medical Center, Chicago, IL
  • Richard L. Roudebush VA Medical Center, Indianapolis, IN
  • VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA
  • VA Ann Arbor Healthcare System, Ann Arbor, MI
  • Minneapolis VA Health Care System, Minneapolis, MN
  • Kansas City VA Medical Center, Kansas City, MO
  • St. Louis VA Medical Center John Cochran Division, St. Louis, MO
  • New Mexico VA Health Care System, Albuquerque, NM
  • VA Western New York Healthcare System, Buffalo, NY
  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
  • Durham VA Medical Center, Durham, NC
  • Cincinnati VA Medical Center, Cincinnati, OH
  • Louis Stokes VA Medical Center, Cleveland, OH
  • Dayton VA Medical Center, Dayton, OH
  • Oklahoma City VA Medical Center, Oklahoma City, OK
  • Portland VA Medical Center, Portland, OR
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
  • Ralph H. Johnson VA Medical Center, Charleston, SC
  • Memphis VA Medical Center, Memphis, TN
  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
  • Michael E. DeBakey VA Medical Center, Houston, TX
  • South Texas Health Care System, San Antonio, TX
  • VA Salt Lake City Health Care System, Salt Lake City, UT
  • Hunter Holmes McGuire VA Medical Center, Richmond, VA
  • Salem VA Medical Center, Salem, VA
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA
  • Canberra Hospital
  • Concord Hospital
  • Gosford Hospital
  • Nepean Hospital
  • St. George Hospital
  • Liverpool Hospital
  • Royal North Shore Hospital
  • Flinders Medical Centre
  • Northern Health
  • Austin Health
  • Fremantle Hospital
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • Penang Hospital
  • Hospital Serdang
  • University of Malaya Medical Center
  • Taranaki Base Hospital
  • Wellington Hospital
  • Auckland City Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Saline & oral placebo

Saline & oral N-acetylcysteine

Bicarbonate & oral placebo

Bicarbonate & oral N-acetylcysteine

Arm Description

IV isotonic saline and oral placebo drug capsule

IV isotonic saline and oral N-acetylcysteine drug capsule

IV isotonic bicarbonate and oral placebo drug capsule

IV isotonic bicarbonate and oral N-acetylcysteine drug capsule

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 26, 2011
Last Updated
September 21, 2022
Sponsor
VA Office of Research and Development
Collaborators
The George Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01467466
Brief Title
Prevention of Serious Adverse Events Following Angiography
Acronym
PRESERVE
Official Title
CSP #578 - Prevention of Serious Adverse Events Following Angiography (PRESERVE)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 7, 2013 (Actual)
Primary Completion Date
September 29, 2017 (Actual)
Study Completion Date
October 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
The George Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 7,680 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure, Kidney Disease, Coronary Artery Disease
Keywords
renal, cardiovascular, kidney, heart, clinical trial, double-blind, multi-site trial, randomized, drug treatment, IV solutions, antioxidant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saline & oral placebo
Arm Type
Active Comparator
Arm Description
IV isotonic saline and oral placebo drug capsule
Arm Title
Saline & oral N-acetylcysteine
Arm Type
Active Comparator
Arm Description
IV isotonic saline and oral N-acetylcysteine drug capsule
Arm Title
Bicarbonate & oral placebo
Arm Type
Active Comparator
Arm Description
IV isotonic bicarbonate and oral placebo drug capsule
Arm Title
Bicarbonate & oral N-acetylcysteine
Arm Type
Active Comparator
Arm Description
IV isotonic bicarbonate and oral N-acetylcysteine drug capsule
Intervention Type
Drug
Intervention Name(s)
IV isotonic saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
IV isotonic bicarbonate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
NAC
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Within 90 days following angiography
Title
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.
Description
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.
Time Frame
Within 90 days following angiography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven D. Weisbord, MD MSc
Organizational Affiliation
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Official's Role
Study Chair
Facility Information:
Facility Name
Southern Arizona VA Health Care System, Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205-5484
Country
United States
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States
Facility Name
San Francisco VA Medical Center, San Francisco, CA
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Bay Pines VA Healthcare System, Pay Pines, FL
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33708
Country
United States
Facility Name
North Florida/South Georgia Veterans Health System, Gainesville, FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Charlie Norwood VA Medical Center, Augusta, GA
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904
Country
United States
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Jesse Brown VA Medical Center, Chicago, IL
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States
Facility Name
VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA
City
West Roxbury
State/Province
Massachusetts
ZIP/Postal Code
02132
Country
United States
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48113
Country
United States
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Kansas City VA Medical Center, Kansas City, MO
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Facility Name
New Mexico VA Health Care System, Albuquerque, NM
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108-5153
Country
United States
Facility Name
VA Western New York Healthcare System, Buffalo, NY
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Cincinnati VA Medical Center, Cincinnati, OH
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Dayton VA Medical Center, Dayton, OH
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
Oklahoma City VA Medical Center, Oklahoma City, OK
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Portland VA Medical Center, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States
Facility Name
Memphis VA Medical Center, Memphis, TN
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
South Texas Health Care System, San Antonio, TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center, Richmond, VA
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Salem VA Medical Center, Salem, VA
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Canberra Hospital
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
Concord Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Gosford Hospital
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Northern Health
City
Epping
State/Province
Victoria
ZIP/Postal Code
3076
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Penang Hospital
City
George Town
State/Province
Penang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Hospital Serdang
City
Sepang
State/Province
Selangor
ZIP/Postal Code
43300
Country
Malaysia
Facility Name
University of Malaya Medical Center
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
Taranaki Base Hospital
City
Westown
State/Province
New Plymouth
ZIP/Postal Code
4310
Country
New Zealand
Facility Name
Wellington Hospital
City
Newtown
State/Province
Wellington
ZIP/Postal Code
1142
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1142
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30466822
Citation
Garcia S, Bhatt DL, Gallagher M, Jneid H, Kaufman J, Palevsky PM, Wu H, Weisbord SD; PRESERVE Trial Group. Strategies to Reduce Acute Kidney Injury and Improve Clinical Outcomes Following Percutaneous Coronary Intervention: A Subgroup Analysis of the PRESERVE Trial. JACC Cardiovasc Interv. 2018 Nov 26;11(22):2254-2261. doi: 10.1016/j.jcin.2018.07.044.
Results Reference
result
PubMed Identifier
31547939
Citation
Parikh CR, Liu C, Mor MK, Palevsky PM, Kaufman JS, Thiessen Philbrook H, Weisbord SD. Kidney Biomarkers of Injury and Repair as Predictors of Contrast-Associated AKI: A Substudy of the PRESERVE Trial. Am J Kidney Dis. 2020 Feb;75(2):187-194. doi: 10.1053/j.ajkd.2019.06.011. Epub 2019 Sep 20.
Results Reference
result
PubMed Identifier
32192658
Citation
Weisbord SD, Palevsky PM, Kaufman JS, Wu H, Androsenko M, Ferguson RE, Parikh CR, Bhatt DL, Gallagher M; PRESERVE Trial Investigators. Contrast-Associated Acute Kidney Injury and Serious Adverse Outcomes Following Angiography. J Am Coll Cardiol. 2020 Mar 24;75(11):1311-1320. doi: 10.1016/j.jacc.2020.01.023.
Results Reference
result
PubMed Identifier
34136794
Citation
Bullen AL, Cashion W, Webster L, Palevsky PM, Weisbord SD, Ix JH. Estimated Urinary Flow Rate and Contrast-Associated Acute Kidney Injury Risk: The PRESERVE (Prevention of Serious Adverse Events Following Angiography) Trial. Kidney Med. 2021 Feb 27;3(3):461-463. doi: 10.1016/j.xkme.2020.12.014. eCollection 2021 May-Jun. No abstract available.
Results Reference
result
PubMed Identifier
36008352
Citation
Soomro QH, Anand ST, Weisbord SD, Gallagher MP, Ferguson RE, Palevsky PM, Bhatt DL, Parikh CR, Kaufman JS; PRESERVE Trial Investigators; PRESERVE Trial Group. The Relationship between Rate and Volume of Intravenous Fluid Administration and Kidney Outcomes after Angiography. Clin J Am Soc Nephrol. 2022 Oct;17(10):1446-1456. doi: 10.2215/CJN.02160222. Epub 2022 Aug 25.
Results Reference
result
PubMed Identifier
29130810
Citation
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.
Results Reference
derived

Learn more about this trial

Prevention of Serious Adverse Events Following Angiography

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