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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216459
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
maha abou-zeid, 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.


Condition or disease Intervention/treatment Phase
Major Trauma Sepsis Drug: oral lactobacillus probiotics plus intramuscular cholecalciferol Drug: intravenous vitamin C plus thiamine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Anti-inflammatory and Anti-microbial Co-supplementations in Traumatic ICU Patients at High Risk of Sepsis
Actual Study Start Date : February 18, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Thiamine

Arm Intervention/treatment
No Intervention: Low risk group
no specific treatment will be given
No Intervention: High risk control
no specific treatment will be given
Active Comparator: 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
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

Active Comparator: 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
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216459


Contacts
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Contact: Maha Ahmed Abozeid, MD 02-01019216192 mahazed@mans.edu.eg
Contact: Noha Ashraf, Bachelor 02-01024981202 n.ashraf@mans.edu.eg

Locations
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Egypt
Mansoura University-Emergency hospital-ICU Recruiting
Mansoura, Egypt
Contact: Maha Abozeid, MD    00201019216192    Mahazed@mans.edu.eg   
Contact: Noha Ashraf Mostafa    00201024981202    na1741993@gmail.com   
Sponsors and Collaborators
Mansoura University
Investigators
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Study Director: Maha Ahmed Abozeid, MD Faculty of Medicine - Mansoura University
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Responsible Party: maha abou-zeid, lecturer of Anesthesia and Surgical Intensive Care, Mansoura University
ClinicalTrials.gov Identifier: NCT04216459    
Other Study ID Numbers: high risk of sepsis
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Cholecalciferol
Ascorbic Acid
Thiamine
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamin B Complex