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

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

Sponsors

Lead Sponsor: Mansoura University

Source 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.

Overall Status Recruiting
Start Date 2020-02-18
Completion Date 2021-06-01
Primary Completion Date 2020-11-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Acute Physiology and Chronic Health Evaluation II (APACHE II) score 0n the Day 0-Day 6 from onset of trauma
Secondary Outcome
Measure Time Frame
Sequential Organ Failure Assessment (SOFA) score 0n the Day 0-Day 6 from onset of trauma
Monocyte chemo attractant protein 1 (MCP-1) 0n the Day 0-Day 6 from onset of trauma
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: oral lactobacillus probiotics plus intramuscular cholecalciferol

Description: 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

Arm Group Label: High risk DP

Intervention Type: Drug

Intervention Name: intravenous vitamin C plus thiamine

Description: 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

Arm Group Label: High risk CB

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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Maha Ahmed Abozeid, MD Study Director Faculty of Medicine - Mansoura University
Overall Contact

Last Name: Maha Ahmed Abozeid, MD

Phone: 02-01019216192

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Mansoura University-Emergency hospital-ICU Maha Abozeid, MD 00201019216192 [email protected]
Location Countries

Egypt

Verification Date

2020-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Mansoura University

Investigator Full Name: maha abou-zeid

Investigator Title: lecturer of Anesthesia and Surgical Intensive Care

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Low risk group

Type: No Intervention

Description: no specific treatment will be given

Label: High risk control

Type: No Intervention

Description: no specific treatment will be given

Label: High risk DP

Type: Active Comparator

Description: 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

Label: High risk CB

Type: Active Comparator

Description: 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

Acronym DrNoha-ICU
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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