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

Sepsis Clinical Trial

— DrNoha-ICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216459
• Other study ID #: high risk of sepsis
• Status: Completed
• Phase: N/A
• Start date: February 18, 2020
• Est. completion date: October 4, 2021

Study information

• Verified date: October 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: October 4, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Major Trauma
• Sepsis
• Toxemia

Intervention

Drug:
• oral lactobacillus probiotics plus intramuscular cholecalciferol
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
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

Locations

Country	Name	City	State
Egypt	Mansoura University-Emergency hospital-ICU	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Physiology and Chronic Health Evaluation II (APACHE II) score	minim 0 maximum 71 Increasing score is associated with increasing risk of ICU mortality	0n the Day 0-Day 6 from onset of trauma
Secondary	Sequential Organ Failure Assessment (SOFA) score	minim 0 maximum 24 The acute increase of 2 or more in SOFA points indicates sepsis	0n the Day 0-Day 6 from onset of trauma
Secondary	Monocyte chemo attractant protein 1 (MCP-1)	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	0n the Day 0-Day 6 from onset of trauma