Jin H Han1, Adit A Ginde2, Samuel M Brown3, Adrienne Baughman4, Erin M Collar5, E Wesley Ely6, Michelle N Gong7, Aluko A Hope7, Peter C Hou8, Catherine L Hough9, Theodore J Iwashyna10, James C Jackson11, Akram Khan9, Onur M Orun12, Mayur B Patel13, Rameela Raman12, Todd W Rice14, Nancy Ringwood15, Matthew W Semler14, Nathan I Shapiro16, Daniel S Talmor17, Wesley H Self4. 1. Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, TN; Department of Emergency Medicine, Vanderbilt University Medical Center, TN; Geriatric Research, Education, and Clinical Center, Tennessee Valley Healthcare System, Healthcare System. Electronic address: jin.h.han@vumc.org. 2. Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO. 3. Division of Pulmonary/Critical Care Medicine, Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City, UT. 4. Department of Emergency Medicine, Vanderbilt University Medical Center, TN. 5. Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, TN; Division of Allergy, Pulmonary, and Critical Care, Vanderbilt University Medical Center, TN. 6. Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, TN; Division of Allergy, Pulmonary, and Critical Care, Vanderbilt University Medical Center, TN; Geriatric Research, Education, and Clinical Center, Tennessee Valley Healthcare System, Healthcare System. 7. Division of Critical Care, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY. 8. Division of Emergency Critical Care Medicine, Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA. 9. Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health & Science University, Portland, OR. 10. Division of Pulmonary and Critical Care, Department of Medicine, University of Michigan, Ann Arbor, MI; Center for Clinical Management Research, VA Ann Arbor, Ann Arbor, MI. 11. Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, TN; Geriatric Research, Education, and Clinical Center, Tennessee Valley Healthcare System, Healthcare System. 12. Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, TN; Department of Biostatistics, Vanderbilt University Medical Center, TN. 13. Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, TN; Division of Trauma, Emergency Surgery, & Surgical Critical Care, Department of Surgery, Section of Surgical Sciences, Departments of Neurosurgery, and Hearing & Speech Sciences, Vanderbilt University Medical Center, TN; Geriatric Research, Education, and Clinical Center, Tennessee Valley Healthcare System, Healthcare System. 14. Division of Allergy, Pulmonary, and Critical Care, Vanderbilt University Medical Center, TN. 15. Massachusetts General Hospital, Boston, MA. 16. Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA. 17. Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.
Abstract
BACKGROUND: Long-term cognitive impairment frequently occurs after critical illness; no treatments are known to improve long-term cognition. RESEARCH QUESTION: Does a single high-dose (540,000 International Units) enteral treatment of vitamin D3 given shortly after hospital admission in critically ill patients who are vitamin D deficient improve long-term global cognition or executive function? STUDY DESIGN AND METHODS: This study evaluated long-term cognitive outcomes among patients enrolled in a multicenter, blinded, randomized clinical trial comparing vitamin D3 treatment vs placebo in critically ill adults with vitamin D deficiency. Global cognition was measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Executive function was measured with a composite score derived from three Delis-Kaplan Executive Function System subscales. Outcomes were assessed at a median of 443 days (interquartile range, 390-482 days) after randomization and were compared using multivariate proportional odds regression. Adjusted ORs of > 1.0 would indicate better outcomes in the vitamin D3 group compared with the placebo group. RESULTS: Ninety-five patients were enrolled, including 47 patients randomized to vitamin D3 treatment and 48 patients randomized to placebo. The adjusted median RBANS score at follow-up was 79.6 (95% CI, 73.0-84.0) in the vitamin D3 group and 82.1 (95% CI, 74.7-84.6) in the placebo group (adjusted OR, 0.83; 95% CI, 0.50-1.38). The adjusted median executive function composite scores were 8.1 (95% CI, 6.8-9.0) and 8.7 (95% CI, 7.4-9.3), respectively (adjusted OR, 0.72; 95% CI, 0.36-1.42). INTERPRETATION: In vitamin D-deficient, critically-ill adults, a large dose of enteral vitamin D3 did not improve long-term global cognition or executive function. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03733418; URL: www.clinicaltrials.gov. Published by Elsevier Inc.
BACKGROUND: Long-term cognitive impairment frequently occurs after critical illness; no treatments are known to improve long-term cognition. RESEARCH QUESTION: Does a single high-dose (540,000 International Units) enteral treatment of vitamin D3 given shortly after hospital admission in critically ill patients who are vitamin D deficient improve long-term global cognition or executive function? STUDY DESIGN AND METHODS: This study evaluated long-term cognitive outcomes among patients enrolled in a multicenter, blinded, randomized clinical trial comparing vitamin D3 treatment vs placebo in critically ill adults with vitamin D deficiency. Global cognition was measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Executive function was measured with a composite score derived from three Delis-Kaplan Executive Function System subscales. Outcomes were assessed at a median of 443 days (interquartile range, 390-482 days) after randomization and were compared using multivariate proportional odds regression. Adjusted ORs of > 1.0 would indicate better outcomes in the vitamin D3 group compared with the placebo group. RESULTS: Ninety-five patients were enrolled, including 47 patients randomized to vitamin D3 treatment and 48 patients randomized to placebo. The adjusted median RBANS score at follow-up was 79.6 (95% CI, 73.0-84.0) in the vitamin D3 group and 82.1 (95% CI, 74.7-84.6) in the placebo group (adjusted OR, 0.83; 95% CI, 0.50-1.38). The adjusted median executive function composite scores were 8.1 (95% CI, 6.8-9.0) and 8.7 (95% CI, 7.4-9.3), respectively (adjusted OR, 0.72; 95% CI, 0.36-1.42). INTERPRETATION: In vitamin D-deficient, critically-ill adults, a large dose of enteral vitamin D3 did not improve long-term global cognition or executive function. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03733418; URL: www.clinicaltrials.gov. Published by Elsevier Inc.
Entities:
Keywords:
ICU; executive function; global cognition; vitamin D
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