Major TraumaDrNoha-ICUNCT04216459
Effect of Anti-inflammatory and Anti-microbial Co-supplementations in Traumatic ICU Patients at High Risk of Sepsis
A study testing oral lactobacillus probiotics plus intramuscular cholecalciferol and intravenous vitamin C plus thiamine in people with Major Trauma and Sepsis, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Trauma, Sepsis
- What is being tested?
- oral lactobacillus probiotics plus intramuscular cholecalciferol and intravenous vitamin C plus thiamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Feb 2020to 4 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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.
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- oral lactobacillus probiotics plus intramuscular cholecalciferol, intravenous vitamin C plus thiamine
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral lactobacillus probiotics plus intramuscular cholecalciferolDrug
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 thiamineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: intravenous vitamin C plus thiamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
minim 0 maximum 71 Increasing score is associated with increasing risk of ICU mortality
Measured: 0n the Day 0-Day 6 from onset of trauma
Secondary outcomes (2)
Sequential Organ Failure Assessment (SOFA) score
minim 0 maximum 24 The acute increase of 2 or more in SOFA points indicates sepsis
Measured: 0n the Day 0-Day 6 from onset of trauma
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
Measured: 0n the Day 0-Day 6 from onset of trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start18 Feb 2020
- Primary completion30 Nov 2020
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major TraumaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
- Investigators
- Maha Ahmed Abozeid, MD, Study director, Faculty of Medicine - Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216459
- Sponsor's protocol ID
- high risk of sepsis
- Acronym
- DrNoha-ICU
- Status last verified
- Oct 2021
- First submitted
- 30 Dec 2019
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34912231
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anti-inflammatory and Anti-microbial Co-supplementations in Traumatic ICU Patients at High Risk of Sepsis
- ClinicalTrials.gov ID
- NCT04216459
- Acronym / sponsor ID
- DrNoha-ICU / high risk of sepsis
- Conditions
- Major Trauma, Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: oral lactobacillus probiotics plus intramuscular cholecalciferolpatients 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 |
| High risk CB | Active comparator | Drug: intravenous vitamin C plus thiaminePatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (15 listed)
- • Patients admitted to ICU after time exceeding 24 hours from trauma onset.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral lactobacillus probiotics plus intramuscular cholecalciferolAccording 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 | Drug | High risk DP |
| intravenous vitamin C plus thiaminestarting 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 | High risk CB |
Primary outcome
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
2 secondary outcomes
Sequential Organ Failure Assessment (SOFA) score
Time frame: 0n the Day 0-Day 6 from onset of trauma
Monocyte chemo attractant protein 1 (MCP-1)
Time frame: 0n the Day 0-Day 6 from onset of trauma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Derived from this study: PubMed 34912231Kamel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha Ahmed Abozeid, MD study director
Faculty of Medicine - Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral lactobacillus probiotics plus intramuscular cholecalciferol and intravenous vitamin C plus thiamine in people with Major Trauma and Sepsis, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Physiology and Chronic Health Evaluation II (APACHE II) score (time frame: 0n the Day 0-Day 6 from onset of trauma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04216459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.