Michael V Rocco1, Kaycee M Sink2, Laura C Lovato3, Dawn F Wolfgram4, Thomas B Wiegmann5, Barry M Wall6, Kausik Umanath7, Frederic Rahbari-Oskoui8, Anna C Porter9, Roberto Pisoni10, Cora E Lewis11, Julia B Lewis12, James P Lash9, Lois A Katz13, Amret T Hawfield14, William E Haley15, Barry I Freedman14, Jamie P Dwyer12, Paul E Drawz16, Mirela Dobre17, Alfred K Cheung18, Ruth C Campbell10, Udayan Bhatt19, Srinivasan Beddhu18, Paul L Kimmel20, David M Reboussin3, Glenn M Chertow21. 1. Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, NC. Electronic address: mrocco@wakehealth.edu. 2. Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, NC. 3. Division of Public Health Sciences, Department of Biostatistical Sciences, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, NC. 4. Section of Nephrology, Department of Medicine, Zablocki VA Medical Center, Milwaukee, WI; Division of Nephrology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI. 5. Department of Clinical Research, Veterans Affairs Hospital, Kansas City, MO. 6. University of Tennessee Health Science Center, Memphis, TN; Department of Veterans Affairs Medical Center, Memphis, TN. 7. Division of Nephrology and Hypertension, Henry Ford Hospital, Detroit, MI. 8. Renal Division, Department of Medicine, Emory University School of Medicine, Atlanta, GA. 9. Section of Nephrology, Department of Medicine, University of Illinois at Chicago, Chicago, IL. 10. Division of Nephrology, Department of Medicine, Medical University of South Carolina, Charleston, SC. 11. Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL. 12. Division of Nephrology/Hypertension, Vanderbilt University Medical Center, Nashville, TN. 13. VA New York Harbor Healthcare System and New York University School of Medicine, New York, NY. 14. Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, NC. 15. Division of Nephrology and Hypertension, Mayo Clinic, Jacksonville, FL. 16. Division of Renal Diseases & Hypertension, University of Minnesota, Minneapolis, MN. 17. Division of Nephrology and Hypertension, Department of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH. 18. Division of Nephrology & Hypertension, University of Utah, Salt Lake City, UT; Medical Service, Department of Veterans Affairs, Salt Lake City Healthcare System, Salt Lake City, UT. 19. Division of Nephrology, The Ohio State University Wexner Medical Center, Columbus, OH. 20. Division of Kidney Urologic and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD. 21. Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Palo Alto, CA.
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 <140mmHg (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.
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 <140mmHg (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.
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