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

Not Applicable

Completed

• Conditions: Major Trauma; Sepsis
• Interventions: Drug: intravenous vitamin C plus thiamine; Drug: oral lactobacillus probiotics plus intramuscular cholecalciferol

• Registration Number: NCT04216459
• Lead Sponsor: Mansoura University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Study Start: 2020-02-18
• Primary Completion: 2020-11-30
• Status Verified: 2021-10
• Study Completion: 2021-10-04
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High risk CB	intravenous vitamin C plus thiamine	Patients will receive vitamin C plus thiamine starting from day 1 in a dose of 1 gm vitamin C and 200 mg thiamine intravenous 4 times at 12-hour intervals for 48 hours
High risk DP	oral lactobacillus probiotics plus intramuscular cholecalciferol	patients will receive one intramuscular (IM) injection of 400,000 IU of cholecalciferol on day- 1 Also, starting from day 1 and till day 6 (for consequential 6 days), patients will receive lactobacillus probiotics (10 billion colony forming unit) in a dose of 6 sachets per day

Primary Outcome Measures

Name	Time	Method
Acute Physiology and Chronic Health Evaluation II (APACHE II) score	0n the Day 0-Day 6 from onset of trauma	minim 0 maximum 71 Increasing score is associated with increasing risk of ICU mortality

Secondary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment (SOFA) score	0n the Day 0-Day 6 from onset of trauma	minim 0 maximum 24 The acute increase of 2 or more in SOFA points indicates sepsis
Monocyte chemo attractant protein 1 (MCP-1)	0n the Day 0-Day 6 from onset of trauma	Optimum cut-off value of MCP-1 for prediction of sepsis in severe trauma ICU patients is 240.7 pg/ml The decrease in its level indicates less inflammatory response and better patient out comes

Trial Locations

Locations (1)

Mansoura University-Emergency hospital-ICU; 🇪🇬 Mansoura, Egypt