Prevention of Serious Adverse Events Following Angiography

PHASE3CompletedINTERVENTIONAL
Enrollment

5,177

Participants

Timeline

Start Date

October 7, 2013

Primary Completion Date

September 29, 2017

Study Completion Date

October 17, 2017

Conditions
Acute Renal FailureKidney DiseaseCoronary Artery Disease
Interventions
DRUG

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.

DRUG

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.

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.

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.

Trial Locations (54)

1142

Wellington Hospital, Newtown

Auckland City Hospital, Auckland

2065

Royal North Shore Hospital, St Leonards

2139

Concord Hospital, Concord

2170

Liverpool Hospital, Liverpool

2217

St. George Hospital, Kogarah

2250

Gosford Hospital, Gosford

2606

Canberra Hospital, Canberra

2747

Nepean Hospital, Kingswood

3076

Northern Health, Epping

3084

Austin Health, Heidelberg

4310

Taranaki Base Hospital, Westown

5042

Flinders Medical Centre, Bedford Park

6000

Royal Perth Hospital, Perth

6009

Sir Charles Gairdner Hospital, Nedlands

6160

Fremantle Hospital, Fremantle

10010

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY, New York

10990

Penang Hospital, George Town

14215

VA Western New York Healthcare System, Buffalo, NY, Buffalo

15240

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA, Pittsburgh

23249

Hunter Holmes McGuire VA Medical Center, Richmond, VA, Richmond

24153

Salem VA Medical Center, Salem, VA, Salem

27705

Durham VA Medical Center, Durham, NC, Durham

30033

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur

30904

Charlie Norwood VA Medical Center, Augusta, GA, Augusta

32608

North Florida/South Georgia Veterans Health System, Gainesville, FL, Gainesville

33708

Bay Pines VA Healthcare System, Pay Pines, FL, Bay Pines

38104

Memphis VA Medical Center, Memphis, TN, Memphis

43300

Hospital Serdang, Sepang

44106

Louis Stokes VA Medical Center, Cleveland, OH, Cleveland

45220

Cincinnati VA Medical Center, Cincinnati, OH, Cincinnati

45428

Dayton VA Medical Center, Dayton, OH, Dayton

48113

VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor

50603

University of Malaya Medical Center, Kuala Lumpur

55417

Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis

60612

Jesse Brown VA Medical Center, Chicago, IL, Chicago

63106

St. Louis VA Medical Center John Cochran Division, St. Louis, MO, St Louis

64128

Kansas City VA Medical Center, Kansas City, MO, Kansas City

73104

Oklahoma City VA Medical Center, Oklahoma City, OK, Oklahoma City

75216

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas

77030

Michael E. DeBakey VA Medical Center, Houston, TX, Houston

78229

South Texas Health Care System, San Antonio, TX, San Antonio

84148

VA Salt Lake City Health Care System, Salt Lake City, UT, Salt Lake City

85723

Southern Arizona VA Health Care System, Tucson, Tucson

90073

VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles

94121

San Francisco VA Medical Center, San Francisco, CA, San Francisco

97201

Portland VA Medical Center, Portland, OR, Portland

98108

VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle

72205-5484

Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR, Little Rock

94304-1290

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto

46202-2884

Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis

02132

VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA, West Roxbury

87108-5153

New Mexico VA Health Care System, Albuquerque, NM, Albuquerque

29401-5799

Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston

All Listed Sponsors
collaborator

The George Institute

OTHER

lead

VA Office of Research and Development

FED

NCT01467466 - Prevention of Serious Adverse Events Following Angiography | Biotech Hunter | Biotech Hunter