Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Health-Related Quality of Life in Sepsis

Anne V Grossestreuer, Ari Moskowitz, Lars W Andersen, Mathias J Holmberg, Varun Konacki, Katherine M Berg, Maureen Chase, Michael N Cocchi, Michael W Donnino, Anne V Grossestreuer, Ari Moskowitz, Lars W Andersen, Mathias J Holmberg, Varun Konacki, Katherine M Berg, Maureen Chase, Michael N Cocchi, Michael W Donnino

Abstract

Patients who experience sepsis often have long-term effects that may impact health-related quality of life. This study aimed to investigate whether the combination of ascorbic acid, corticosteroids, and thiamine compared with placebo improves health-related quality of life in patients with septic shock.

Design: Secondary analysis of the Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis randomized controlled trial (NCT03389555).

Setting: Thirteen tertiary-care hospitals in the United States.

Patients: Patients who were enrolled in Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis, survived to 90 days post enrollment and were able to be contacted by telephone.

Interventions: Patients were randomly assigned to parenteral ascorbic acid (1,500 mg), hydrocortisone (50 mg), and thiamine (100 mg) every 6 hours for 4 days or placebo.

Measurements and main results: One hundred seventeen patients (59%) survived to 90 days and were administered the Short Form 36 questionnaire; of these, 72 (62%) completed the Short Form 36 (38 [53%] in the intervention group, 34 [47%] in placebo). Sixty-six (92%) completed all survey questions (36 [95%] in the intervention group, 30 [88%] in placebo). There was no significant difference in overall Short Form 36 score between intervention and placebo group (median score: 39.4 [interquartile range, 31.2-45.4] vs 43.2 [37.0-46.7], respectively, p = 0.18). We found no statistically significant difference between the two groups in any of the other health-related quality of life domains used.

Conclusions: We found no difference in the health-related quality of life in patients with septic shock treated with a combination of ascorbic acid, corticosteroids, and thiamine compared to placebo.

Keywords: ascorbic acid; corticosteroids; quality of life; sepsis; thiamine.

Conflict of interest statement

Dr. Grossestreuer reported receipt of grants from Harvard Catalyst Medical Research Investigator Training. Drs. Donnino, Moskowitz, and Berg reported receipt of grants from the National Institutes of Health. The remaining authors have not disclosed any potential conflicts of interest.

Copyright © 2020 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine.

Figures

Figure 1.
Figure 1.
Patient enrollment. ACTS = Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis, IRB = Institutional Review Board, SF-36 = Short Form 36.

References

    1. Rudd KE, Johnson SC, Agesa KM, et al. : Global, regional, and national sepsis incidence and mortality, 1990-2017: Analysis for the global burden of disease study Lancet. 2020; 395:200–211
    1. Yende S, Austin S, Rhodes A, et al. : Long-term quality of life among survivors of severe sepsis: Analyses of two international trials. Crit Care Med. 2016; 44:1461–1467
    1. Mostel Z, Perl A, Marck M, et al. : Post-sepsis syndrome - an evolving entity that afflicts survivors of sepsis. Mol Med. 2019; 26:6.
    1. Winters BD, Eberlein M, Leung J, et al. : Long-term mortality and quality of life in sepsis: A systematic review. Crit Care Med. 2010; 38:1276–1283
    1. Moskowitz A, Yankama T, Andersen LW, et al. ; ACTS Clinical Trial Investigators. Ascorbic acid, corticosteroids and thiamine in sepsis (ACTS) protocol and statistical analysis plan: A prospective, multicentre, double-blind, randomised, placebo-controlled clinical trial. BMJ Open. 2019; 9:e034406
    1. Moskowitz A, Andersen LW, Huang DT, et al. : Ascorbic acid, corticosteroids, and thiamine in sepsis: A review of the biologic rationale and the present state of clinical evaluation. Crit Care. 2018; 22:283.
    1. Hays RD, Sherbourne CD, Mazel RM.The RAND 36-Item Health Survey 1.0. Health Econ. 1993; 2:217–227
    1. Schmidt K, Worrack S, Von Korff M, et al. ; SMOOTH Study Group. Effect of a primary care management intervention on mental health-related quality of life among survivors of sepsis: A randomized clinical trial. JAMA. 2016; 315:2703–2711
    1. Ryan P: SF36: Stata Module to Calculate Summary Statistics for the SF-36 Health Survey Instrument. 1999, Boston, MA: Statistical Software Components S377601, Boston College Department of Economics
    1. Nannan Panday RS, Minderhoud TC, Chantalou DS, et al. : Health related quality of life in sepsis survivors from the Prehospital antibiotics against sepsis (PHANTASi) trial. PLoS One. 2019; 14:e0222450.
    1. Hammond NE, Finfer SR, Li Q, et al. ; ADRENAL Trial Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Health-related quality of life in survivors of septic shock: 6-month follow-up from the ADRENAL trial. Intensive Care Med. 2020; 46:1696–1706

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner