Clinical trial NCT04216459: Effect of Anti-inflammatory and Anti-microbial Co-supplementations in Traumatic ICU Patients at High Risk of Sepsis
Official title: Effect of Anti-inflammatory and Anti-microbial Co-supplementations in Traumatic ICU Patients at High Risk of Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Trauma
Sepsis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: Acute Physiology and Chronic Health Evaluation II (APACHE II) score
timeFrame: 0n the Day 0-Day 6 from onset of trauma
Secondary outcomes:
measure: Sequential Organ Failure Assessment (SOFA) score
timeFrame: 0n the Day 0-Day 6 from onset of trauma
measure: Monocyte chemo attractant protein 1 (MCP-1)
timeFrame: 0n the Day 0-Day 6 from onset of trauma
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University-Emergency hospital-ICU
Study officials:
affiliation: Faculty of Medicine - Mansoura University
name: Maha Ahmed Abozeid, MD
role: STUDY_DIRECTOR
References:
citation: Kamel NA, Soliman MM, Abo-Zeid MA, Shaaban MI. Effect of Anti-Inflammatory and Antimicrobial Cosupplementations on Sepsis Prevention in Critically Ill Trauma Patients at High Risk for Sepsis. Front Pharmacol. 2021 Nov 29;12:792741. doi: 10.3389/fphar.2021.792741. eCollection 2021.