Evidence map›Paper›PMID 27543797›Full record

Trial reportJournal of the American Heart Association2016

ABT-719 for the Prevention of Acute Kidney Injury in Patients Undergoing High-Risk Cardiac Surgery: A Randomized Phase 2b Clinical Trial.

Peter A McCullough, Elliott Bennett-Guerrero, Lakhmir S Chawla, Thomas Beaver, Ravindra L Mehta, Bruce A Molitoris, Ann Eldred, Greg Ball, Ho-Jin Lee, Mark T Houser and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Heart Association, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01777165 (A Phase 2b, Randomized, Double-Blind,Placebo-Controlled, Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
4.1field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01777165 phase2completednot on this map

A Phase 2b, Randomized, Double-Blind,Placebo-Controlled, Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery

TypeinterventionalSponsorAbbVieRan2013 to 2014Enrolled240ConditionsAcute Kidney InjuryArmsABT-719, Placebo
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 40 citations in OpenAlex.

  1. Trial
  2. Perioperative THR-184 and AKI after Cardiac Surgery.Journal of the American Society of Nephrology : JASN · 2018
    Trial
  3. Review
  4. Review
  5. Drugs in treating paediatric acute kidney injury.Pediatric nephrology (Berlin, Germany) · 2023
    Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Review
  12. Targeting acute kidney injury in COVID-19.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2020
    Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Review
  18. Article
  19. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 1 country.

Peter A McCulloughTexas A&M, Department of Internal Medicine Baylor University Medical Center, Baylor Heart and Vascular Institute, Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas, TX The Heart Hospital, Plano, TX peteramccullough@gmail.com.
Elliott Bennett-GuerreroStony Brook Medicine Health Science Center, Stony Brook, NY.
Lakhmir S ChawlaGeorge Washington School of Medicine, Department of Internal Medicine, Veterans Affairs Medical Center, Washington, DC.
Thomas BeaverDepartment of Thoracic and Cardiovascular Surgery, University of Florida, Gainesville, FL.
Ravindra L MehtaDepartment of Internal Medicine, University of California San Diego Medical Center, San Diego, CA.
Bruce A MolitorisDepartment of Internal Medicine, Indiana University, Indianapolis, IN.
Ann EldredRenal Clinical Development, AbbVie Inc., North Chicago, IL.
Greg BallStatistics, AbbVie Inc., North Chicago, IL.
Ho-Jin LeeStatistics, AbbVie Inc., North Chicago, IL.
Mark T HouserRenal Clinical Development, AbbVie Inc., North Chicago, IL.
Samina KhanRenal Clinical Development, AbbVie Inc., North Chicago, IL.
AbbVie (United States) · USBaylor University Medical Center · USIndiana University – Purdue University Indianapolis · USStony Brook Medicine · USUniversity of California San Diego Medical Center · USUniversity of Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients undergoing cardiac surgeries with cardiopulmonary bypass (on-pump) have a high risk for acute kidney injury (AKI). We tested ABT-719, a novel α-melanocyte-stimulating hormone analog, for prevention of AKI in postoperative cardiac surgery patients. METHODS AND

resultsThis phase 2b randomized, double-blind, placebo-controlled trial included adult patients with stable renal function undergoing high-risk on-pump cardiac surgery in the United States and Denmark. Participants received placebo (n=61) or cumulative ABT-719 doses of 800 (n=59), 1600 (n=61), or 2100 μg/kg (n=59). Primary outcome was development of AKI based on Acute Kidney Injury Network (AKIN) criteria, measured utilizing preoperative creatinine value and maximum value within 48 hours and urine output within the first 42 hours postsurgery. Secondary outcomes included incidence of AKI based on maximal changes from baseline in novel AKI biomarkers over a 72-hour period after clamp release and length of intensive care unit stays through 90 days postsurgery. A total of 65.5%, 62.7%, and 69.6% of patients in the 800-, 1600-, and 2100-μg/kg groups, respectively, developed AKI (stages 1, 2, and 3 combined) versus 65.5% in the placebo group (for each pair-wise comparison with placebo, P=0.966, 0.815, and 0.605, respectively). Adverse events occurred at a similar rate in all treatment groups.

conclusionsABT-719 treatment did not lower AKI incidence using AKIN criteria, influence the elevations of novel biomarkers, or change 90-day outcomes in patients after cardiac surgery. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique Identifier: NCT01777165.

Indexed as

Acute Kidney InjuryAgedBiomarkersCardiopulmonary BypassCritical CareDouble-Blind MethodFemaleHumansLength of StayMalePatient SafetyPostoperative ComplicationsPyridonesRenal AgentsRisk FactorsTreatment OutcomeABT 719BiomarkersPyridonesRenal Agentsacute kidney injurycardiopulmonary bypassclinical trialkidneyrenalrenal functionα‐melanocyte‐stimulating hormone

Identifiers

PMID27543797
PMCPMC5015281
OpenAlexW2510147549

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.