Effects of Intensive Blood Pressure Treatment on Acute Kidney Injury Events in the Systolic Blood Pressure Intervention Trial (SPRINT)

Michael V. Rocco, Kaycee M. Sink, Laura C. Lovato, Dawn F. Wolfgram, Thomas B. Wiegmann, Barry M. Wall, Kausik Umanath, Frederic Rahbari-Oskoui, Anna C. Porter, Roberto Pisoni, Cora E. Lewis, Julia B. Lewis, James P. Lash, Lois A. Katz, Amret T. Hawfield, William E. Haley, Barry I. Freedman, Jamie P. Dwyer, Paul E. Drawz, Mirela DobreAlfred K. Cheung, Ruth C. Campbell, Udayan Bhatt, Srinivasan Beddhu, Paul L. Kimmel, David M. Reboussin, Glenn M. Chertow, on behalf of the, SPRINT Research Group

Research output: Contribution to journalArticlepeer-review

66 Scopus citations

Abstract

Background: Treating to a lower blood pressure (BP) may increase acute kidney injury (AKI) events. Study Design: Data for AKI resulting in or during hospitalization or emergency department visits were collected as part of the serious adverse events reporting process of the Systolic Blood Pressure Intervention Trial (SPRINT). Setting & Participants: 9,361 participants 50 years or older with 1 or more risk factors for cardiovascular disease. Interventions: Participants were randomly assigned to a systolic BP target of <120 (intensive arm) or <140 mm Hg (standard arm). Outcomes & Measurements: Primary outcome was the number of adjudicated AKI events. Secondary outcomes included severity of AKI and degree of recovery of kidney function after an AKI event. Baseline creatinine concentration was defined as the most recent SPRINT outpatient creatinine value before the date of the AKI event. Results: There were 179 participants with AKI events in the intensive arm and 109 in the standard arm (3.8% vs 2.3%; HR, 1.64; 95% CI, 1.30-2.10; P < 0.001). Of 288 participants with an AKI event, 248 (86.1%) had a single AKI event during the trial. Based on modified KDIGO (Kidney Disease: Improving Global Outcomes) criteria for severity of AKI, the number of AKI events in the intensive versus standard arm by KDIGO stage was 128 (58.5%) versus 81 (62.8%) for AKI stage 1, 42 (19.2%) versus 18 (14.0%) for AKI stage 2, and 42 (19.2%) versus 25 (19.4%) for AKI stage 3 (P = 0.5). For participants with sufficient data, complete or partial resolution of AKI was seen for 169 (90.4%) and 9 (4.8%) of 187 AKI events in the intensive arm and 86 (86.9%) and 4 (4.0%) of 99 AKI events in the standard arm, respectively. Limitations: Trial results are not generalizable to patients with diabetes mellitus or without risk factors for cardiovascular disease. Conclusions: More intensive BP lowering resulted in more frequent episodes of AKI. Most cases were mild and most participants had complete recovery of kidney function. Trial Registration: Registered at ClinicalTrials.gov with study number NCT01206062.

Original languageEnglish (US)
Pages (from-to)352-361
Number of pages10
JournalAmerican Journal of Kidney Diseases
Volume71
Issue number3
DOIs
StatePublished - Mar 2018

Bibliographical note

Funding Information:
Support : Supported by contracts ( HHSN268200900040C , HHSN268200900046C , HHSN268200900047C , HHSN268200900048C , and HHSN268200900049C ) and an interagency agreement (A-HL-13-002-001) from the NIH , including the NHLBI, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Institute of Neurological Disorders and Stroke. Several study sites were supported by Clinical and Translational Science Awards funded by the National Center for Advancing Translational Sciences of the NIH (Case Western Reserve University: UL1TR000439 ; Ohio State University: UL1RR025755 ; University of Pennsylvania: UL1RR024134 and UL1TR000003 ; Boston University: UL1RR025771 ; Stanford University: UL1TR000093 ; Tufts University: UL1RR025752 , UL1TR000073 , and UL1TR001064 ; University of Illinois: UL1TR000050 ; University of Pittsburgh: UL1TR000005 ; University of Texas Southwestern: 9U54TR000017-06 ; University of Utah: UL1TR000105-05 ; Vanderbilt University: UL1TR000445 ; George Washington University: UL1TR000075 ; University of California, Davis: UL1TR000002 ; University of Florida: UL1TR000064 ; University of Michigan: UL1TR000433 ; and Tulane University: P30GM103337 Centers of Biomedical Research Excellence Award National Institute of General Medical Sciences). The trial was also supported in part with respect to resources and the use of facilities by the Department of Veterans Affairs. Azilsartan and chlorthalidone (combined with azilsartan) were provided by Takeda Pharmaceuticals International Inc. The SPRINT Steering Committee was responsible for the design and conduct of the study, including the collection and management of the data. Scientists at the NIH as a group and the principal investigator of the Veterans Affairs clinical network had 1 vote on the Steering Committee of the trial. There were 7 voting members of the Steering Committee. The NIH, the US Department of Veterans Affairs, and the US government had no role in analysis and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Funding Information:
Support: Supported by contracts (HHSN268200900040C, HHSN268200900046C, HHSN268200900047C, HHSN268200900048C, and HHSN268200900049C) and an interagency agreement (A-HL-13-002-001) from the NIH, including the NHLBI, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Institute of Neurological Disorders and Stroke. Several study sites were supported by Clinical and Translational Science Awards funded by the National Center for Advancing Translational Sciences of the NIH (Case Western Reserve University: UL1TR000439; Ohio State University: UL1RR025755; University of Pennsylvania: UL1RR024134 and UL1TR000003; Boston University: UL1RR025771; Stanford University: UL1TR000093; Tufts University: UL1RR025752, UL1TR000073, and UL1TR001064; University of Illinois: UL1TR000050; University of Pittsburgh: UL1TR000005; University of Texas Southwestern: 9U54TR000017-06; University of Utah: UL1TR000105-05; Vanderbilt University: UL1TR000445; George Washington University: UL1TR000075; University of California, Davis: UL1TR000002; University of Florida: UL1TR000064; University of Michigan: UL1TR000433; and Tulane University: P30GM103337 Centers of Biomedical Research Excellence Award National Institute of General Medical Sciences). The trial was also supported in part with respect to resources and the use of facilities by the Department of Veterans Affairs. Azilsartan and chlorthalidone (combined with azilsartan) were provided by Takeda Pharmaceuticals International Inc. The SPRINT Steering Committee was responsible for the design and conduct of the study, including the collection and management of the data. Scientists at the NIH as a group and the principal investigator of the Veterans Affairs clinical network had 1 vote on the Steering Committee of the trial. There were 7 voting members of the Steering Committee. The NIH, the US Department of Veterans Affairs, and the US government had no role in analysis and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Publisher Copyright:
© 2017 National Kidney Foundation, Inc.

Keywords

  • Acute kidney injury (AKI)
  • BP lowering
  • adjudicated AKI episode
  • cardiovascular disease (CKD)
  • chronic kidney disease (CKD)
  • elderly
  • hypertension
  • kidney function
  • systolic blood pressure (SBP)

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