Effect of Anti-inflammatory and Anti-microbial Co-supplementations in Traumatic ICU Patients at High Risk of Sepsis

• Status: Completed
• Trial end date: 2021-10-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents; Anti-Inflammatory Agents; Ascorbic Acid; Cholecalciferol; Thiamine

Criteria

Inclusion Criteria:

• Adult trauma patients admitted to ICU within 24 hours from trauma onset with injury severity score (ISS) ≥ 16 will be recruited after obtaining informed consent

Exclusion Criteria:

• • Patients admitted to ICU after time exceeding 24 hours from trauma onset.

• Patients whose age is less than 18 years.

• Pregnant female.

• Breast feeding women.

• Arrest within 24 hours of admission.

• Immune deficiency or administration of immune suppressant drugs.

• Serum calcium greater than or equal to 10 mg/dl or phosphate greater than or equal 6 mg/dl.

• History of primary parathyroid disease.

• Metabolic bone disease.

• Sarcoidosis.

• End stage renal disease.

• receiving intermittent renal replacement therapy (RRT).

• Failure of enteral feeding or any contraindication to enteral administration.

• Obesity , body mass index (BMI > 35 kg/m2)

• Known contraindication to vitamin C or thiamine (oxalate nephropathy or known glucose-6-phosphate dehydrogenase deficiency)