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Early Vitamin C and Thiamine Administration to Patients with Septic Shock in Emergency Departments: Propensity Score-Based Analysis of a Before-and-After Cohort Study.

ABSTRACT: Intravenous vitamin C and thiamine administration may be a potential adjuvant therapy for septic shock. We aimed to investigate the impact of early vitamin C and thiamine administration in septic shock patients. This retrospective before-and-after cohort study used data extracted from the Korean Shock Society's prospective septic shock registry. We compared 28-day and in-hospital mortality rates between patients treated with intravenous vitamin C (3 g/12 h or 1.5 g/6 h) and thiamine (200 mg/12 h) <6 hours after shock recognition from July through December 2017 (n = 229) and control patients from October 2015 through June 2017 (n = 915) using propensity score matching. The 28-day (18.3% vs. 17.5%; P = 0.76) and in-hospital (16.6% vs. 18.3%; P = 0.55) mortality rates did not differ between treatment and control groups, nor did 28-day (18.5% vs. 17.5%; P = 0.84) and in-hospital (16.7% vs. 18.4%; P = 0.54) mortality rates after matching. In the subgroup analysis, treatment was associated with lower in-hospital mortality rates in patients with albumin <3.0 mg/dL or a Sequential Organ Failure Assessment (SOFA) score >10. Early vitamin C and thiamine administration in patients with septic shock did not improve survival; however, administration could benefit conditions that are more severe, such as hypoalbuminemia or severe organ failure.

SUBMITTER: Shin TG

PROVIDER: S-EPMC6352246 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Early Vitamin C and Thiamine Administration to Patients with Septic Shock in Emergency Departments: Propensity Score-Based Analysis of a Before-and-After Cohort Study.

Shin Tae Gun TG Kim Youn-Jung YJ Ryoo Seung Mok SM Hwang Sung Yeon SY Jo Ik Joon IJ Chung Sung Phil SP Choi Sung-Hyuk SH Suh Gil Joon GJ Kim Won Young WY

Journal of clinical medicine 20190116 1

<h4>Background</h4>Intravenous vitamin C and thiamine administration may be a potential adjuvant therapy for septic shock. We aimed to investigate the impact of early vitamin C and thiamine administration in septic shock patients.<h4>Methods</h4>This retrospective before-and-after cohort study used data extracted from the Korean Shock Society's prospective septic shock registry. We compared 28-day and in-hospital mortality rates between patients treated with intravenous vitamin C (3 g/12 h or 1. ...[more]

PMID: 30654592

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Project description:BackgroundThe combination therapy of hydrocortisone, vitamin C, and thiamine has been proposed as a potential treatment in patients with sepsis and septic shock. However, subsequent trials have reported conflicting results in relation to survival outcomes. Hence, we performed this randomized controlled trial (RCT) to evaluate the efficacy and safety of early combination therapy among adult patients with septic shock.MethodsThis single-center, double-blind RCT enrolled adult patients with diagnosis of septic shock within 12 h from Northern Jiangsu People's Hospital between February 2019 and June 2021. Recruited patients were randomized 1:1 to receive intervention (hydrocortisone 200 mg daily, vitamin C 2 g every 6 h, and thiamine 200 mg every 12 h) or placebo (0.9% saline) for 5 days or until ICU discharge. The primary endpoint was 90-day mortality. The secondary endpoints included mortality at day 28, ICU discharge, and hospital discharge; shock reversal; 72-h Delta SOFA score; ICU-free days, vasopressor-free days, and ventilator support -free days up to day 28; ICU length of stay (LOS) and hospital LOS.ResultsAmong 426 patients randomized, a total of 408 patients with septic shock were included in the per-protocol (PP) analysis, of which 203 were assigned to the intervention group and 205 to the placebo group. In the PP population, the primary outcome of 90-day mortality was 39.9% (81/203) and 39.0% (80/205) in the intervention and the placebo groups, respectively, and was not significantly different (P = 0.86). There was no significant difference between two groups in 28-day mortality (36.5% vs. 36.1%, P = 0.94) or the ICU mortality (31.5% vs. 28.8%, P = 0.55) and hospital mortality (34.5% vs. 33.2%, P = 0.78). No other secondary outcomes showed significant differences between two groups, including shock reversal, vasopressor-free days, and ICU LOS. Intention-to-treat analysis included all the 426 patients and confirmed these results (all P > 0.05).ConclusionAmong adult patients with septic shock, early use of hydrocortisone, vitamin C, and thiamine combination therapy compared with placebo did not confer survival benefits. Trial registration ClinicalTrials.gov: NCT03872011 , registration date: March 12, 2019.

Project description:BackgroundIntravenous vitamin C administration in septic shock may have a sparing effect on vasopressor requirements, and vitamin C's enzyme cofactor functions provide a mechanistic rationale. Our study aimed to determine the effect of intravenous vitamin C administration on vasopressor requirements and other outcomes in patients with septic shock.MethodsThis was a double-blind, randomised placebo-controlled trial in 40 patients with septic shock who were randomised (1:1) to receive intravenous vitamin C (at a dose of 25 mg/kg of body weight every 6 h) or placebo (intravenous 5% dextrose) for up to 96 h, or until death or discharge. The primary outcome was intravenous vasopressor requirements (dose and duration), and secondary outcomes included Sequential Organ Failure Assessment (SOFA) scores, intensive care unit (ICU) and hospital length of stay, and mortality. In addition, blood samples were collected to determine vitamin C kinetics and inflammatory marker concentrations.ResultsMedian plasma vitamin C concentrations were deficient at baseline (9.2 [4.4, 12] µmol/L) and increased to 408 (227, 560) µmol/L following 72 h of intervention. The mean duration of intravenous vasopressor infusion in the vitamin C group was 48 (95% CI 35-62) hours and in the placebo group was 54 (95% CI 41-62) hours (p = 0.52). The dose of vasopressor delivered over time was comparable between the two groups, as were SOFA scores (p > 0.05). The median ICU length of stay in the intervention group was 3.8 (2.2, 9.8) days versus 7.1 (3.1, 20) days in the placebo group (p = 0.12). The median hospital length of stay for the vitamin C group was 18 (11, 35) days versus 22 (10, 52) days for the placebo group (p = 0.65). Mortality was comparable between the two groups (p > 0.05). Of the inflammatory markers, neutrophil counts were elevated in the vitamin C group relative to placebo by 72 h (p = 0.01). C-reactive protein and myeloperoxidase concentrations were elevated at baseline, however, the two groups were comparable over time (p > 0.05).ConclusionsOur pilot study indicated that intravenous vitamin C did not provide significant decreases in the mean dose or duration of vasopressor infusion. Further research that takes into account the potential impact of intervention timing, dose and duration, and location of trial, may provide more definitive evidence.Trial registrationACTRN12617001184369 (11/8/2017).

Dataset Information

Early Vitamin C and Thiamine Administration to Patients with Septic Shock in Emergency Departments: Propensity Score-Based Analysis of a Before-and-After Cohort Study.

Publications

Early Vitamin C and Thiamine Administration to Patients with Septic Shock in Emergency Departments: Propensity Score-Based Analysis of a Before-and-After Cohort Study.

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