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Clinical Trial Summary

The occurrence of sepsis in trauma patients is a very serious complication. Identifying trauma patients at high risk of sepsis was not revealed in the latest surviving sepsis campaign in 2016. Several biomarkers have been proposed for early prediction of sepsis in trauma patients as leukocyte anti sedimentation rate (LAR) and the proinflammatory cytokine monocyte chemo attractant protein-1 (MCP-1). Sepsis prophylaxis before occurrence of multi-organ failure still represents a major challenge. Vitamin D and probiotics have antimicrobial, anti-inflammatory and gut microbiota immune modulatory properties.Little is known about the effect of vitamin D and probiotics co-supplementation on the inflammatory response in trauma patients at high risk of sepsis. Another promising strategy is the use of vitamin C in addition to thiamine. Trauma is associated with increased oxidative stress and vitamin C deficiency. High dose vitamin C is required to restore oxidant-antioxidant balance. Vitamin C and thiamine have shown promising results in treatment of sepsis. Vitamin C possesses anti-inflammatory, endothelial protective and anti-microbial effects. Thiamine is the precursor of thiamine pyrophosphate (TPP), a key enzyme in Krebs cycle.


Clinical Trial Description

This study will investigate effect of vitamin D and probiotics versus Vitamin C and thiamine on inflammatory response (represented by change in MCP-1 level), Sequential Organ Failure Assessment (SOFA) Score and Acute Physiology and Chronic Health Evaluation II (APACHE II) in trauma patients at high risk of sepsis. Secondary goal is to assess if the predictive ability of MCP-1 plus LAR to determine high risk of sepsis in major trauma intensive care patients and if there is correlation between LAR and MCP-1. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04216459
Study type Interventional
Source Mansoura University
Contact
Status Completed
Phase N/A
Start date February 18, 2020
Completion date October 4, 2021

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