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VA Cooperative Studies Program (CSP)

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CSP #578: Prevention of Serious Adverse Events Following Angiography (PRESERVE)

 

Investigator Access

What's available?

Pending

Available Documentation

Study protocol & statistical analysis plan available in full text of Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine

Dates Data are Available

Upon completion of study objectives

Access Criteria

Investigators associated with VA or non-VA nonprofit, academic, or research institutions may submit a Research Resource Request form to Lauren.Harris2@va.gov.

Investigators may be asked to provide further documentation such as a study proposal. All requests are reviewed for scientific and ethical merit. Access is contingent upon approval by the requestor’s Institutional Review Board (IRB) and, if applicable, a VA Research and Development (R&D) Committee. To gain access, requestors must sign a VA data use agreement. Requestors must be fully compliant with VA data security, privacy, and human subjects requirements.

Study Characteristics

Objectives

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.

Era of Service

All

Population

Patients of VA medical centers who were scheduled to undergo angiography and who were at high risk for renal complications. Population was predominantly male (>90%).

Study Design

Randomized double-blinded clinical trial

Interventions 

  • Arm 1: sodium chloride + placebo
  • Arm 2: sodium chloride + acetylcysteine
  • Arm 3: sodium bicarbonate + placebo
  • Arm 4: sodium chloride + acetylcysteine

Time Period

February 2013 - October 2017

Setting

53 medical sites (35 VA sites in the United States and 18 non-VA international sites in Australia, Malaysia, New Zealand)

N

4,993

Response Rate

N/A

Recruitment Method

Study coordinators reviewed angiography logs/schedules to identify patients scheduled for angiography and assessed their electronic medical records for eligibility. Providers introduced patients to the study and research personnel completed the screening process.

Compensation

  • None for study-related blood draws done by the mobile specimen collection agency
  • Travel expense reimbursement provided for study-related blood draws not done by the mobile specimen collection agency

Data Collected

Primary outcome

  • Composite of serious, adverse events, including death, need for acute dialysis, or persistent decline in kidney function within 90 days following angiography

Secondary outcomes

  • Contrast-associated acute kidney injury
  • Death within 90 days
  • Dialysis of any kind within 90 days
  • Confirmed persistent kidney impairment at 90-104 days
  • All-cause re-hospitalization within 90 days

Tertiary outcomes

  • Development of end-stage renal disease within one year
  • Death within one year

Other assessments

  • Demographics
  • Clinical characteristics (e.g., co-morbid conditions, history of hypertension, weight, smoking history)
  • Serum creatinine
  • Albumin, creatinine, and pH

Data Collection Methods

  • Blood and urine samples
  • Participant interviews
  • Review of the electronic medical records

Funding Source

  • VA Cooperative Studies Program (CSP)
  • National Health and Medical Research Council of Australia

Contact

Lauren.Harris2@va.gov

Selected Publication

Weisbord SD, Gallagher M, Kaufman J, Cass A, Parikj CR, Chertow GM, Shunk KA, McCullough PA, Fine MJ, Mor MK, Lew RA, Huang GD, Conner TA, Brophy MT, Lee J, Soliva S, Palevsky PM. Prevention of contrast-induced AKI: a review of published trials and the design of the prevention of serious adverse events following angiography (PRESERVE) trial. Clin J Am Soc Nephrol. 2013 Sep;8(9):1618-1631.

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 angiographic with sodium bicarbonate and acetylcysteine. N Engl J Med. 2018 Feb;378(7):603-614.

More Information

Study ClinicalTrials.gov site
ClinicalTrials.gov Identifier: NCT01467466