Effect of Anti-Inflammatory and Antimicrobial Cosupplementations on Sepsis Prevention in Critically Ill Trauma Patients at High Risk for Sepsis

Noha A Kamel, Moetaza M Soliman, Maha A Abo-Zeid, Mona I Shaaban, Noha A Kamel, Moetaza M Soliman, Maha A Abo-Zeid, Mona I Shaaban

Abstract

Background: Sepsis development in patients with trauma is associated with bad prognosis. This study investigated the effect of immunomodulatory interventions in major trauma patients at high risk for sepsis. Methods: In a randomized, double-blinded, controlled design, severe trauma patients were stratified by leukocyte anti-sedimentation rate (LAR) test into high risk (HR) and low risk (LR) for sepsis. The HR patients were randomly allocated into intravenous vitamin C plus vitamin B1 (HR-CB), intramuscular vitamin D plus oral Lactobacillus probiotics (HR-DP), or control (HR-C) groups. The clinical trial was registered at clinicaltrials.gov (https://ichgcp.net/clinical-trials-registry/NCT04216459). Outcomes: The primary outcome was Acute Physiologic Assessment and Chronic Health Evaluation score II (APACHE II) score. Secondary outcomes included sepsis incidence, changes in Sequential Organ Failure Assessment (SOFA) score, and serum monocyte chemoattractant protein-1 (MCP-1) on day 6 from baseline, 28-day mortality, intensive care unit (ICU), and hospital discharge. Results: The HR-DP, HR-CB, and LR groups showed a significantly lower incidence of sepsis development (20%, 20%, and 16%, respectively, versus 60% in the HR-C group, p-value = 0.004). The three groups also showed a significant improvement in APACHE II and SOFA scores. Besides, MCP-1 levels were significantly decreased in HR-DP and HR-CB groups compared to the HR-C group (p-value ≤ 0.05). Significantly decreased mortality (10% and 16% versus 60% in the HR-C group) and increased ICU discharge (95% and 84% versus 45% in the HR-C group) were observed in HR-CB and LR groups (p-value = 0.001). Conclusion: Both combinations of interventions improved APACHE II scores and reduced sepsis incidence in trauma patients. The LAR combined with injury severity score were good sepsis predictors.

Keywords: controlled trial; leukocyte antisedimentation rate; monocyte chemoattractant protein 1; probiotics; sepsis; vitamin B1; vitamin C; vitamin D.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Kamel, Soliman, Abo-Zeid and Shaaban.

Figures

FIGURE 1
FIGURE 1
Flow chart of patient enrollment process. ICH: intracerebral hemorrhage, ISS: injury severity score, ESRD: end-stage renal disease, RRT: renal replacement therapy, LR: low risk for sepsis group, HR-C: high risk for sepsis control group, HR-DP: high risk for sepsis vitamin D and probiotics group, HR-CB: high risk for sepsis vitamin C and vitamin B1 group, MCP-1: monocyte chemoattractant protein-1. LAR: leukocyte anti-sedimentation rate.
FIGURE 2
FIGURE 2
Number of patients who developed sepsis besides the duration of mechanical ventilation for patients mechanically ventilated from day 0 in each group by the end of the first week. (A) Number of patients developing sepsis (by the end of the first week) in each group. (B) Days of mechanical ventilation for patients ventilated from day 0 in each group. (* = significant compared to HR-C group, p-value ≤ 0.05). LR: low risk for sepsis group, HR-C: high risk for sepsis control group, HR-DP: high risk for sepsis vitamin D and probiotics group, HR-CB: high risk for sepsis vitamin C and vitamin B1 group. Data are number (incidence), median (IQR).
FIGURE 3
FIGURE 3
Number of patients discharged from the ICU, from the hospital or died during the first 28 days in each group. (A) ICU discharge within 28 days. (B) Hospital discharge within 28 days. (C) The 28-day hospital mortality in each group (* = significant compared to HR-C group, p-value ≤ 0.05). LR: low risk for sepsis group, HR-C: high risk for sepsis control group, HR-DP: high risk for sepsis vitamin D and probiotics group, HR-CB: high risk for sepsis vitamin C and vitamin B1 group. Data are number (incidence).
FIGURE 4
FIGURE 4
Kaplan–Meier survival estimates of ICU Mortality HR-C: High risk for sepsis control group, HR-DP: High risk for sepsis vitamin D and probiotics group, HR-CB: High risk for sepsis vitamin C and vitamin B1 group, SE: standard error, 95% CI: 95% confidence interval, ꭕ2: chi-square, * = Significant compared to HR-C group, p-value ≤ 0.05.
FIGURE 5
FIGURE 5
Receiver operating characteristics (ROC) curve for predictive value of different sepsis predictors among non-intervention groups (HR-C and LR groups). MCP-1: Monocyte chemoattractant protein-1, ISS: Injury severity score. LAR: Leukocyte anti sedimentation rate. SE: standard error. # = Significant p-value. Significance level at p ≤ 0.05.

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