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

NCT ID: NCT04216459

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-18
• Study Completion Date: 2021-10-04

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.

Conditions

Major Trauma; Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Low risk group

no specific treatment will be given

Group Type: NO_INTERVENTION

No interventions assigned to this group

High risk control

no specific treatment will be given

Group Type: NO_INTERVENTION

No interventions assigned to this group

High risk DP

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

Group Type: ACTIVE_COMPARATOR

oral lactobacillus probiotics plus intramuscular cholecalciferol

Intervention Type: 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 CB

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

Group Type: ACTIVE_COMPARATOR

intravenous vitamin C plus thiamine

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

maha abou-zeid

lecturer of Anesthesia and Surgical Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maha Ahmed Abozeid, MD

Role: STUDY_DIRECTOR

Faculty of Medicine - Mansoura University

Locations

Mansoura University-Emergency hospital-ICU

Al Mansurah, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 34912231 (View on PubMed)

Other Identifiers

high risk of sepsis

Identifier Type: -

Identifier Source: org_study_id