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

NCT04216459 | Completed DMC

• 1 other identifier: high risk of sepsis
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Trauma; Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (4)

Low risk group

NO INTERVENTION

no specific treatment will be given

High risk control

NO INTERVENTION

no specific treatment will be given

High risk DP

ACTIVE COMPARATOR

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

Drug: oral lactobacillus probiotics plus intramuscular cholecalciferol

High risk CB

ACTIVE COMPARATOR

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

Drug: intravenous vitamin C plus thiamine

Interventions

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

High risk DP

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

High risk CB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University-Emergency hospital-ICU

Al Mansurah, Egypt

Location

Related Publications (1)

• 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.

  PMID: 34912231 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Thiamine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Maha Ahmed Abozeid, MD

  Faculty of Medicine - Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Anesthesia and Surgical Intensive Care

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 2, 2020
• Study Start: February 18, 2020
• Primary Completion: November 30, 2020
• Study Completion: October 4, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

EG (1)