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Massive VA trial tests cheap ways to protect kidneys during heart procedures

NCT ID NCT01467466

Prevention Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large study tested whether giving sodium bicarbonate (a type of fluid) or N-acetylcysteine (a supplement) before and after angiography could prevent serious kidney problems, including death or need for dialysis. Over 5,000 high-risk patients with kidney disease took part. The goal was to find a simple, affordable way to protect patients during these common heart procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sodium bicarbonate and N-acetylcysteine
What this could lead to
If successful, this could establish a simple, low-cost way to prevent kidney damage and other serious complications after angiography in people with existing kidney disease.
What could go wrong
This trial is already completed, so results are known. The interventions may not prove better than standard care, and the study focused on a specific high-risk group, so findings may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

5,177 people

The number who actually took part.

Started

Oct 2013

Finished

Oct 2017

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic kidney disease coronary artery disorder impaired renal function disease kidney disorder acute kidney injury prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute renal failure Coronary artery disease Kidney disease

Contacts and locations

Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033, United States

  • Auckland City Hospital

    Auckland, Auckland, 1142, New Zealand

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Bay Pines VA Healthcare System, Pay Pines, FL

    Bay Pines, Florida, 33708, United States

  • Canberra Hospital

    Canberra, Australian Capital Territory, 2606, Australia

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

    Little Rock, Arkansas, 72205-5484, United States

  • Charlie Norwood VA Medical Center, Augusta, GA

    Augusta, Georgia, 30904, United States

  • Cincinnati VA Medical Center, Cincinnati, OH

    Cincinnati, Ohio, 45220, United States

  • Concord Hospital

    Concord, New South Wales, 2139, Australia

  • Dayton VA Medical Center, Dayton, OH

    Dayton, Ohio, 45428, United States

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705, United States

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Fremantle Hospital

    Fremantle, Western Australia, 6160, Australia

  • Gosford Hospital

    Gosford, New South Wales, 2250, Australia

  • Hospital Serdang

    Sepang, Selangor, 43300, Malaysia

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    Richmond, Virginia, 23249, United States

  • Jesse Brown VA Medical Center, Chicago, IL

    Chicago, Illinois, 60612, United States

  • Kansas City VA Medical Center, Kansas City, MO

    Kansas City, Missouri, 64128, United States

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106, United States

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

    New York, New York, 10010, United States

  • Memphis VA Medical Center, Memphis, TN

    Memphis, Tennessee, 38104, United States

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

    Houston, Texas, 77030, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417, United States

  • Nepean Hospital

    Kingswood, New South Wales, 2747, Australia

  • New Mexico VA Health Care System, Albuquerque, NM

    Albuquerque, New Mexico, 87108-5153, United States

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

    Gainesville, Florida, 32608, United States

  • Northern Health

    Epping, Victoria, 3076, Australia

  • Oklahoma City VA Medical Center, Oklahoma City, OK

    Oklahoma City, Oklahoma, 73104, United States

  • Penang Hospital

    George Town, Pulau Pinang, 10990, Malaysia

  • Portland VA Medical Center, Portland, OR

    Portland, Oregon, 97201, United States

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

    Charleston, South Carolina, 29401-5799, United States

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

    Indianapolis, Indiana, 46202-2884, United States

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • Royal Perth Hospital

    Perth, Western Australia, 6000, Australia

  • Salem VA Medical Center, Salem, VA

    Salem, Virginia, 24153, United States

  • San Francisco VA Medical Center, San Francisco, CA

    San Francisco, California, 94121, United States

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009, Australia

  • South Texas Health Care System, San Antonio, TX

    San Antonio, Texas, 78229, United States

  • Southern Arizona VA Health Care System, Tucson

    Tucson, Arizona, 85723, United States

  • St. George Hospital

    Kogarah, New South Wales, 2217, Australia

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

    St Louis, Missouri, 63106, United States

  • Taranaki Base Hospital

    Westown, New Plymouth, 4310, New Zealand

  • University of Malaya Medical Center

    Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48113, United States

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

    West Roxbury, Massachusetts, 02132, United States

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

    West Los Angeles, California, 90073, United States

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

    Dallas, Texas, 75216, United States

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

    Palo Alto, California, 94304-1290, United States

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

    Pittsburgh, Pennsylvania, 15240, United States

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

    Seattle, Washington, 98108, United States

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

    Salt Lake City, Utah, 84148, United States

  • VA Western New York Healthcare System, Buffalo, NY

    Buffalo, New York, 14215, United States

  • Wellington Hospital

    Newtown, Wellington Region, 1142, New Zealand

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