{"title":"Effect of Early Administration of Vitamin D on Clinical Outcome in Critically Ill Sepsis Patients: A Randomized Placebo-controlled Trial.","authors":"Amrita Bhattacharyya, Rajeshwari Subramaniam, Dalim K Baidya, Praveen Aggarwal, Naveet Wig","doi":"10.5005/jp-journals-10071-23993","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Administration of vitamin D to unselected heterogeneous critically ill patients did not demonstrate outcome benefit. The current study was undertaken to identify if early administration of vitamin D can reduce intensive care unit (ICU) length of stay and improve clinical outcomes in critically ill patients with sepsis.</p><p><strong>Methods: </strong>This single-center randomized double-blind placebo-controlled trial was done in the ICU and emergency inpatient ward of a tertiary care teaching institute in New Delhi, India. A total of 126 adult patients aged 18 to 80 years of either sex diagnosed to have sepsis were included within 24 hours of admission to the hospital and randomized into vitamin D or placebo groups. The patients in the intervention group received vitamin D3 540,000 units dissolved in 45 mL of milk. The placebo group received 45 mL of milk.</p><p><strong>Results: </strong>The median length of ICU stay (8 vs 9 days; <i>p</i> = 0.32), median length of hospital stay (12 vs 12 days; <i>p</i> = 0.33), median duration of vasopressors requirement (4 vs 3 days; <i>p</i> = 0.84), median duration of mechanical ventilation (5 vs 7 days; <i>p</i> = 0.23), requirement of tracheostomy (34 vs 39%; <i>p</i> = 0.71), and 90-day mortality [35 vs 46%; <i>p</i> = 0.29; HR 0.72 (0.42-1.24)] were similar in vitamin D and placebo arm.A subgroup analysis in patients with severe vitamin D deficiency (vitamin D <12 ng/mL) revealed a significantly decreased incidence of tracheostomy (28 vs 57%; <i>p</i> = 0.04), a trend toward decreased 90-day mortality [34 vs 66%; <i>p</i> = 0.08; HR 0.44 (0.19-1.01)], and duration of mechanical ventilation (6 vs 11 days; <i>p</i> = 0.05) in patients receiving vitamin D.</p><p><strong>Conclusion: </strong>Administration of large-dose vitamin D within 24 hours of admission does not reduce the length of ICU stay in critically ill sepsis patients.</p><p><strong>How to cite this article: </strong>Bhattacharyya A, Subramaniam R, Baidya DK, Aggarwal P, Wig N. Effect of Early Administration of Vitamin D on Clinical Outcome in Critically Ill Sepsis Patients: A Randomized Placebo-controlled Trial. Indian J Crit Care Med 2021;25(10):1147-1154.</p>","PeriodicalId":520643,"journal":{"name":"Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine","volume":" ","pages":"1147-1154"},"PeriodicalIF":1.5000,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/bd/be/ijccm-25-1147.PMC8645802.pdf","citationCount":"6","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5005/jp-journals-10071-23993","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 6
Abstract
Background: Administration of vitamin D to unselected heterogeneous critically ill patients did not demonstrate outcome benefit. The current study was undertaken to identify if early administration of vitamin D can reduce intensive care unit (ICU) length of stay and improve clinical outcomes in critically ill patients with sepsis.
Methods: This single-center randomized double-blind placebo-controlled trial was done in the ICU and emergency inpatient ward of a tertiary care teaching institute in New Delhi, India. A total of 126 adult patients aged 18 to 80 years of either sex diagnosed to have sepsis were included within 24 hours of admission to the hospital and randomized into vitamin D or placebo groups. The patients in the intervention group received vitamin D3 540,000 units dissolved in 45 mL of milk. The placebo group received 45 mL of milk.
Results: The median length of ICU stay (8 vs 9 days; p = 0.32), median length of hospital stay (12 vs 12 days; p = 0.33), median duration of vasopressors requirement (4 vs 3 days; p = 0.84), median duration of mechanical ventilation (5 vs 7 days; p = 0.23), requirement of tracheostomy (34 vs 39%; p = 0.71), and 90-day mortality [35 vs 46%; p = 0.29; HR 0.72 (0.42-1.24)] were similar in vitamin D and placebo arm.A subgroup analysis in patients with severe vitamin D deficiency (vitamin D <12 ng/mL) revealed a significantly decreased incidence of tracheostomy (28 vs 57%; p = 0.04), a trend toward decreased 90-day mortality [34 vs 66%; p = 0.08; HR 0.44 (0.19-1.01)], and duration of mechanical ventilation (6 vs 11 days; p = 0.05) in patients receiving vitamin D.
Conclusion: Administration of large-dose vitamin D within 24 hours of admission does not reduce the length of ICU stay in critically ill sepsis patients.
How to cite this article: Bhattacharyya A, Subramaniam R, Baidya DK, Aggarwal P, Wig N. Effect of Early Administration of Vitamin D on Clinical Outcome in Critically Ill Sepsis Patients: A Randomized Placebo-controlled Trial. Indian J Crit Care Med 2021;25(10):1147-1154.
背景:对未选择的异质性危重患者给予维生素D治疗并没有显示出结果的益处。目前的研究旨在确定早期给予维生素D是否可以减少重症监护病房(ICU)的住院时间并改善危重症脓毒症患者的临床结果。方法:该单中心随机双盲安慰剂对照试验在印度新德里一家三级护理教学机构的ICU和急诊住院病房进行。在入院24小时内,共有126名年龄在18至80岁之间的成年患者被诊断患有败血症,无论男女,并随机分为维生素D组或安慰剂组。干预组患者给予54万单位的维生素D3溶解在45毫升牛奶中。安慰剂组每天喝45毫升牛奶。结果:ICU住院时间中位数(8天vs 9天;P = 0.32),中位住院时间(12 vs 12天;P = 0.33),血管加压药物所需的中位持续时间(4天vs 3天;P = 0.84),机械通气的中位持续时间(5 vs 7天;P = 0.23),气管切开术的要求(34% vs 39%;P = 0.71), 90天死亡率[35% vs 46%;P = 0.29;在维生素D组和安慰剂组中,HR为0.72(0.42-1.24)。严重维生素D缺乏症患者的亚组分析(维生素D p = 0.04), 90天死亡率有下降趋势[34 vs 66%;P = 0.08;HR 0.44(0.19-1.01)]和机械通气持续时间(6 vs 11天;结论:入院24小时内给予大剂量维生素D并不能缩短危重症脓毒症患者的ICU住院时间。杨建军,杨建军,李建军,等。早期维生素D对重症脓毒症患者临床预后的影响:一项随机对照研究。中华检验医学杂志;2009;25(10):1147-1154。