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Completed

NCT Number: NCT04216459

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

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.

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Key information

Conditions

Major Trauma Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University-Emergency hospital-ICU

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

oral lactobacillus probiotics plus intramuscular cholecalciferol

Drug

According to leukocyte anti- sedimentation rate (LAR) result on day 1 patients will be classified into high risk for sepsis patients (LAR < 15 %) and low risk for sepsis patients (LAR ≥ 15%) High risk sepsis patients will be randomly allocated into one of the 3 groups (sealed opaque envelops) to vitamin D plus probiotics intervention group (HR-DP) group. to vitamin C plus vitamin B intervention group (HR-CB) group. to control group (HR-C) group that does not receive any supplement

intravenous vitamin C plus thiamine

Drug

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

Primary outcomes

  1. Acute Physiology and Chronic Health Evaluation II (APACHE II) score

    Time frame: 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 outcomes

  1. Sequential Organ Failure Assessment (SOFA) score

    Time frame: 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

  2. Monocyte chemo attractant protein 1 (MCP-1)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Acronym: DrNoha-ICU

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jan 2, 2020
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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