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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01467466




Registration number
NCT01467466
Ethics application status
Date submitted
26/10/2011
Date registered
8/11/2011
Date last updated
3/10/2022

Titles & IDs
Public title
Prevention of Serious Adverse Events Following Angiography
Scientific title
CSP #578 - Prevention of Serious Adverse Events Following Angiography (PRESERVE)
Secondary ID [1] 0 0
1011387
Secondary ID [2] 0 0
578
Universal Trial Number (UTN)
Trial acronym
PRESERVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Renal Failure 0 0
Kidney Disease 0 0
Coronary Artery Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IV isotonic saline
Treatment: Drugs - IV isotonic bicarbonate
Treatment: Drugs - N-acetylcysteine
Treatment: Drugs - Placebo

Active Comparator: Saline & oral placebo - IV isotonic saline and oral placebo drug capsule

Active Comparator: Saline & oral N-acetylcysteine - IV isotonic saline and oral N-acetylcysteine drug capsule

Active Comparator: Bicarbonate & oral placebo - IV isotonic bicarbonate and oral placebo drug capsule

Active Comparator: Bicarbonate & oral N-acetylcysteine - IV isotonic bicarbonate and oral N-acetylcysteine drug capsule


Treatment: Drugs: IV isotonic saline
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.

Treatment: Drugs: IV isotonic bicarbonate
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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Within 90 days following angiography
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Within 90 days following angiography

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/10/2017
Sample size
Target
Accrual to date
Final
5177
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Concord Hospital - Concord
Recruitment hospital [3] 0 0
Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [5] 0 0
St. George Hospital - Kogarah
Recruitment hospital [6] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [7] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [8] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [9] 0 0
Northern Health - Epping
Recruitment hospital [10] 0 0
Austin Health - Heidelberg
Recruitment hospital [11] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [12] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [13] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2606 - Canberra
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2747 - Kingswood
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment postcode(s) [6] 0 0
2170 - Liverpool
Recruitment postcode(s) [7] 0 0
2065 - St. Leonards
Recruitment postcode(s) [8] 0 0
5042 - Bedford Park
Recruitment postcode(s) [9] 0 0
3076 - Epping
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
6160 - Fremantle
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment postcode(s) [13] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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New Mexico
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United States of America
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New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
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United States of America
State/province [24] 0 0
Washington
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Malaysia
State/province [25] 0 0
Penang
Country [26] 0 0
Malaysia
State/province [26] 0 0
Selangor
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Malaysia
State/province [27] 0 0
Kuala Lumpur
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New Zealand
State/province [28] 0 0
New Plymouth
Country [29] 0 0
New Zealand
State/province [29] 0 0
Wellington
Country [30] 0 0
New Zealand
State/province [30] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Government body
Name
VA Office of Research and Development
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The George Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01467466
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steven D. Weisbord, MD MSc
Address 0 0
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01467466