Department of Critical Care, Department of Nephrology, Community Medical Center, Toms River, NJ; Department of Nephrology, Jersey Shore University Medical Center, Hackensack Meridian School of Medicine at Seton Hall, Neptune, NJ.
Department of Pharmacy, Community Medical Center, Toms River, NJ.
Chest. 2020 Jul;158(1):164-173. doi: 10.1016/j.chest.2020.02.049. Epub 2020 Mar 17.
Sepsis is a major public health burden resulting in 25% to 30% in-hospital mortality and accounting for over 20 billion dollars of US hospital costs.
Does hydrocortisone, ascorbic acid, thiamine (HAT) therapy improve clinical outcomes in sepsis and septic shock?
This was a randomized, double-blinded, placebo-controlled trial conducted from February 2018 to June 2019, assessing an HAT treatment bundle for the management of septic and septic shock patients admitted to an ICU. The primary outcomes were resolution of shock and change in Sequential Organ Failure Assessment (SOFA) score. Secondary outcomes included 28-day mortality, ICU mortality, hospital mortality, procalcitonin clearance (PCT-c), hospital length of stay (LOS), ICU LOS, and ventilator-free days.
One hundred thirty-seven patients were randomized to the treatment group (n = 68) and comparator group (n = 69), respectively, with no significant differences in baseline characteristics. A statistically significant difference was found in the time patients required vasopressors, indicating quicker reversal of shock in the HAT group compared with the comparator group (27 ± 22 vs 53 ± 38 hours, P < .001). No statistically significant change in SOFA score was found between groups 3 (1 - 6) vs 2 (0 - 4), P = .17. No significant differences were found between study arms in ICU and hospital mortality, ICU and hospital LOS, ventilator free days, and PCT-c.
Our results suggest that the combination of IV ascorbic acid, thiamine, and hydrocortisone significantly reduced the time to resolution of shock. Additional studies are needed to confirm these findings and assess any potential mortality benefit from this treatment.
ClinicalTrials.gov; No.: NCT03422159; URL: www.clinicaltrials.gov.
脓毒症是一个主要的公共卫生负担，导致 25%至 30%的住院患者死亡，并造成超过 200 亿美元的美国医院费用。
氢化可的松、抗坏血酸、硫胺素（HAT）治疗能否改善脓毒症和脓毒性休克患者的临床结局？
这是一项随机、双盲、安慰剂对照试验，于 2018 年 2 月至 2019 年 6 月进行，评估了 ICU 收治的脓毒症和脓毒性休克患者的 HAT 治疗方案。主要结局是休克的缓解和序贯器官衰竭评估（SOFA）评分的变化。次要结局包括 28 天死亡率、ICU 死亡率、医院死亡率、降钙素原清除率（PCT-c）、住院时间（LOS）、ICU LOS 和无呼吸机天数。
137 例患者分别被随机分配到治疗组（n=68）和对照组（n=69），两组患者的基线特征无显著差异。在患者需要血管加压药的时间方面，HAT 组与对照组相比，存在统计学显著差异，表明 HAT 组休克的逆转更快（27±22 与 53±38 小时，P<.001）。两组间 SOFA 评分（3[1-6]与 2[0-4]）无统计学显著差异，P=0.17。研究组之间在 ICU 和医院死亡率、ICU 和医院 LOS、无呼吸机天数和 PCT-c 方面均无显著差异。
我们的结果表明，静脉内抗坏血酸、硫胺素和氢化可的松的联合使用显著缩短了休克缓解的时间。需要进一步的研究来证实这些发现，并评估这种治疗方法是否有任何潜在的死亡率获益。
ClinicalTrials.gov；编号：NCT03422159；网址：www.clinicaltrials.gov。
