Ventilator Associated Pneumonia ( VAP)NCT04029675
High Dose of Vitamin C on Mechanically Ventilated Septic Patients in Intensive Care Unit
A study testing Vitamin C in people with Ventilator Associated Pneumonia ( VAP) and Sepsis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Prospective, Randomized clinical trial study will be carried out in intensive care unit in Ain Shams University Hospitals on 40 forty septic patients admitted to ICU and mechanically ventilated. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ventilator Associated Pneumonia ( VAP), Sepsis
- What is being tested?
- Vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2019to 15 Feb 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female
- Age from age≥18 years
- Septic patient admitted to ICU and mechanically ventilated diagnosed by sepsis criteria proposed by the American College of Chest Physicians/Society of Critical Care Medicine
- Expected to survive and remain in the ICU for at least 96 hours after study entry
Who cannot join
- Age<18 years
- Pregnant females
- Patients with history of aspiration before intubation
- Respiratory distress syndrome
- Ischemic reperfusion injury
- Cancer as the cause of SIRS or sepsis
Show all 9Show fewer
- Chronic kidney diseases
- Ongoing shock
- Allergy from interventional drug on the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High Dose of Vitamin C on the Clinical Outcome of Mechanically Ventilated Patients Following Sepsis in Intensive Care Unit
Prospective, Randomized clinical trial study will be carried out in intensive care unit in Ain Shams University Hospitals on 40 forty septic patients admitted to ICU and mechanically ventilated.
Read the detailed description
This study will be carried out in intensive care unit in Ain Shams University Hospitals , Cairo,Egypt on 40 patients admitted to ICU that are septic patients and mechanically ventilated which will be recruited into the study . After approval from ethical committee, an informed consent will be obtained from relatives of all patients. All data of patients will be confidential with secret codes and private file for each patient. Each patient's relative will receive an explanation for the purpose of the study. The study design will be prospective , randomized clinical trial.
Methodology:
All patients will be subjected to:
- Complete history taking.
- Full clinical examination
- Evaluation and monitoring of(pulse oximetry , ECG, NIBP, temperature)
- CBC , Blood gas (for determination of (PaO2/FiO2), Blood cultures,serum Creatinine and total bilirubin were recorded daily for the first 7 days.
- Severity scores by calculating Acute physiology and chronic health evaluation (APACHE II)score
- Conditions
- Ventilator Associated Pneumonia ( VAP), Sepsis
- Being tested
- Vitamin C
- Keywords
- Vitamin C, Sepsis, Intensive care unit, Mechanically ventilation, VAP
- Medical subject headings
- Pneumonia, Ventilator-Associated, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
Vitamin C is a strong antioxidant and has been shown to regenerate other antioxidants such as vitamin E, vitamin C also play an important role in immune function
| Study group | Role | What they receive |
|---|---|---|
| Study Group ( High dose vitamin C group ) | Experimental | They will receive 1.5 gm intravenous (IV) Vitamin C in 100 ml dextrose 5% (D5W) administered as an infusion over 30 to 60 minutes every 6 hours daily for 4 days or until ICU discharge. Receives: Dietary Supplement: Vitamin C |
| Control Group (Daily requirements vitamin C Group ) | Active comparator | They will receive standard daily requirements of Vitamin C intravenously which is 75-90 mg in 100 ml dextrose 5% (D5W) administered as an infusion over 30 to 60 minutes daily for 4 days or until ICU discharge Receives: Dietary Supplement: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Ventilator -Associated Pneumonia ( VAP)
Ventilator-associated pneumonia (VAP)is defined as pneumonia that occurs 48-72 hours or thereafter following endotracheal intubation, characterized by the presence of a new progressive infiltrate, signs of a systemic infection (fever, altered white blood cells count), changes in sputum characteristics, and detection of a causative agent
Measured: within 28 days
Plasma Vitamin C level after administration of study drug
Vitamin C is a strong antioxidant and has been shown to regenerate other antioxidants such as vitamin E, vitamin C also play an important role in immune function
Measured: within 7 days of administered of vitamin C
change in SOFA score
SOFA (Sepsis -related Organ Failure assessment) score
Measured: within 7 days of administered of vitamin C
Secondary outcomes (5)
28 day Mortality rate
Measured: average 28 days
length of stay in intensive care unit
Measured: through the study completion, average 6 months
changes in Glutathione Peroxidase enzyme (GPX) activity
Measured: within 7 days of administered of vitamin C
duration of vasopressor support
Measured: Average28 days
Ventilator-free days (28-days Cumulative )
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start15 Jul 2019
- Primary completion15 Jan 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated Pneumonia ( VAP)Studies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded ,Prospective, Randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wessam Adel El Sayed Abdel Aziz El Driny, Ain Shams University
- Investigators
- Sara M. Shahen, MD, Study chair, Ain Shams UniversityIbrahim E. Mamdoh, MD, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029675
- Sponsor's protocol ID
- Faculty of Pharmacy_AinShamsU
- Status last verified
- Jul 2020
- First submitted
- 11 Jul 2019
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data that to be shared are age \& gender of the participants
Publications
Annane D, Aegerter P, Jars-Guincestre MC, Guidet B; CUB-Rea Network. Current epidemiology of septic shock: the CUB-Rea Network. Am J Respir Crit Care Med. 2003 Jul 15;168(2):165-72. doi: 10.1164/rccm.2201087.
PubMed 12851245Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003 Apr 17;348(16):1546-54. doi: 10.1056/NEJMoa022139.
PubMed 12700374Sands KE, Bates DW, Lanken PN, Graman PS, Hibberd PL, Kahn KL, Parsonnet J, Panzer R, Orav EJ, Snydman DR, Black E, Schwartz JS, Moore R, Johnson BL Jr, Platt R; Academic Medical Center Consortium Sepsis Project Working Group. Epidemiology of sepsis syndrome in 8 academic medical centers. JAMA. 1997 Jul 16;278(3):234-40.
PubMed 9218672Tanriover MD, Guven GS, Sen D, Unal S, Uzun O. Epidemiology and outcome of sepsis in a tertiary-care hospital in a developing country. Epidemiol Infect. 2006 Apr;134(2):315-22. doi: 10.1017/S0950268805004978.
PubMed 16490136Gogos CA, Drosou E, Bassaris HP, Skoutelis A. Pro- versus anti-inflammatory cytokine profile in patients with severe sepsis: a marker for prognosis and future therapeutic options. J Infect Dis. 2000 Jan;181(1):176-80. doi: 10.1086/315214.
PubMed 10608764CavaillonJ-M.Pathophysiological role of pro-and anti-inflammatory cytokines in sepsis .Sepsis.1998;2(2):127-40.
Kurt AN, Aygun AD, Godekmerdan A, Kurt A, Dogan Y, Yilmaz E. Serum IL-1beta, IL-6, IL-8, and TNF-alpha levels in early diagnosis and management of neonatal sepsis. Mediators Inflamm. 2007;2007:31397. doi: 10.1155/2007/31397.
PubMed 18274637Oda S, Hirasawa H, Shiga H, Nakanishi K, Matsuda K, Nakamua M. Sequential measurement of IL-6 blood levels in patients with systemic inflammatory response syndrome (SIRS)/sepsis. Cytokine. 2005 Feb 21;29(4):169-75. doi: 10.1016/j.cyto.2004.10.010. Epub 2004 Dec 8.
PubMed 15652449Manzanares W, Biestro A, Torre MH, Galusso F, Facchin G, Hardy G. High-dose selenium reduces ventilator-associated pneumonia and illness severity in critically ill patients with systemic inflammation. Intensive Care Med. 2011 Jul;37(7):1120-7. doi: 10.1007/s00134-011-2212-6. Epub 2011 Mar 29.
PubMed 21445641Grossman RF, Fein A. Evidence-based assessment of diagnostic tests for ventilator-associated pneumonia. Executive summary. Chest. 2000 Apr;117(4 Suppl 2):177S-181S. doi: 10.1378/chest.117.4_suppl_2.177s. No abstract available.
PubMed 10816031American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
PubMed 15699079Cook DJ, Walter SD, Cook RJ, Griffith LE, Guyatt GH, Leasa D, Jaeschke RZ, Brun-Buisson C. Incidence of and risk factors for ventilator-associated pneumonia in critically ill patients. Ann Intern Med. 1998 Sep 15;129(6):433-40. doi: 10.7326/0003-4819-129-6-199809150-00002.
PubMed 9735080Leroy O, Sanders V, Girardie P, Devos P, Yazdanpanah Y, Georges H, Beaucaire G. Mortality due to ventilator-associated pneumonia: impact of medical versus surgical ICU admittance status. J Crit Care. 2001 Sep;16(3):90-7. doi: 10.1053/jcrc.2001.28192.
PubMed 11689764Tejerina E, Frutos-Vivar F, Restrepo MI, Anzueto A, Abroug F, Palizas F, Gonzalez M, D'Empaire G, Apezteguia C, Esteban A; Internacional Mechanical Ventilation Study Group. Incidence, risk factors, and outcome of ventilator-associated pneumonia. J Crit Care. 2006 Mar;21(1):56-65. doi: 10.1016/j.jcrc.2005.08.005.
PubMed 16616625Visser J, Labadarios D, Blaauw R. Micronutrient supplementation for critically ill adults: a systematic review and meta-analysis. Nutrition. 2011 Jul-Aug;27(7-8):745-58. doi: 10.1016/j.nut.2010.12.009.
PubMed 21679878
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Dose of Vitamin C on the Clinical Outcome of Mechanically Ventilated Patients Following Sepsis in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04029675
- Acronym / sponsor ID
- Faculty of Pharmacy_AinShamsU
- Conditions
- Ventilator Associated Pneumonia ( VAP), Sepsis
- Keywords
- Vitamin C, Sepsis, Intensive care unit, Mechanically ventilation, VAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 23 Jul 2019 (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.
Prospective, Randomized clinical trial study will be carried out in intensive care unit in Ain Shams University Hospitals on 40 forty septic patients admitted to ICU and mechanically ventilated.
Detailed description
This study will be carried out in intensive care unit in Ain Shams University Hospitals , Cairo,Egypt on 40 patients admitted to ICU that are septic patients and mechanically ventilated which will be recruited into the study . After approval from ethical committee, an informed consent will be obtained from relatives of all patients. All data of patients will be confidential with secret codes and private file for each patient. Each patient's relative will receive an explanation for the purpose of the study. The study design will be prospective , randomized clinical trial.
Methodology:
All patients will be subjected to:
- Complete history taking.
- Full clinical examination
- Evaluation and monitoring of(pulse oximetry , ECG, NIBP, temperature)
- CBC , Blood gas (for determination of (PaO2/FiO2), Blood cultures,serum Creatinine and total bilirubin were recorded daily for the first 7 days.
- Severity scores by calculating Acute physiology and chronic health evaluation (APACHE II)score
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded ,Prospective, Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Study Group ( High dose vitamin C group ) | Experimental | Dietary Supplement: Vitamin CThey will receive 1.5 gm intravenous (IV) Vitamin C in 100 ml dextrose 5% (D5W) administered as an infusion over 30 to 60 minutes every 6 hours daily for 4 days or until ICU discharge. |
| Control Group (Daily requirements vitamin C Group ) | Active comparator | Dietary Supplement: Vitamin CThey will receive standard daily requirements of Vitamin C intravenously which is 75-90 mg in 100 ml dextrose 5% (D5W) administered as an infusion over 30 to 60 minutes daily for 4 days or until ICU discharge |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female
- Age from age≥18 years
- Septic patient admitted to ICU and mechanically ventilated diagnosed by sepsis criteria proposed by the American College of Chest Physicians/Society of Critical Care Medicine
- Expected to survive and remain in the ICU for at least 96 hours after study entry
Key exclusion criteria (9 listed)
- Age<18 years
- Pregnant females
- Patients with history of aspiration before intubation
- Respiratory distress syndrome
- Ischemic reperfusion injury
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 |
|---|---|---|
| Vitamin CVitamin C is a strong antioxidant and has been shown to regenerate other antioxidants such as vitamin E, vitamin C also play an important role in immune function | Dietary supplement | Control Group (Daily requirements vitamin C Group ), Study Group ( High dose vitamin C group ) |
Primary outcome
The Incidence of Ventilator -Associated Pneumonia ( VAP)
Time frame: within 28 days
Ventilator-associated pneumonia (VAP)is defined as pneumonia that occurs 48-72 hours or thereafter following endotracheal intubation, characterized by the presence of a new progressive infiltrate, signs of a systemic infection (fever, altered white blood cells count), changes in sputum characteristics, and detection of a causative agent
Plasma Vitamin C level after administration of study drug
Time frame: within 7 days of administered of vitamin C
Vitamin C is a strong antioxidant and has been shown to regenerate other antioxidants such as vitamin E, vitamin C also play an important role in immune function
change in SOFA score
Time frame: within 7 days of administered of vitamin C
SOFA (Sepsis -related Organ Failure assessment) score
5 secondary outcomes
28 day Mortality rate
Time frame: average 28 days
length of stay in intensive care unit
Time frame: through the study completion, average 6 months
changes in Glutathione Peroxidase enzyme (GPX) activity
Time frame: within 7 days of administered of vitamin C
duration of vasopressor support
Time frame: Average28 days
Ventilator-free days (28-days Cumulative )
Time frame: 28 days
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 21 Jul 2020.
- Background: PubMed 12851245Annane D, Aegerter P, Jars-Guincestre MC, Guidet B; CUB-Rea Network. Current epidemiology of septic shock: the CUB-Rea Network. Am J Respir Crit Care Med. 2003 Jul 15;168(2):165-72. doi: 10.1164/rccm.2201087.
- Background: PubMed 12700374Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003 Apr 17;348(16):1546-54. doi: 10.1056/NEJMoa022139.
- Background: PubMed 9218672Sands KE, Bates DW, Lanken PN, Graman PS, Hibberd PL, Kahn KL, Parsonnet J, Panzer R, Orav EJ, Snydman DR, Black E, Schwartz JS, Moore R, Johnson BL Jr, Platt R; Academic Medical Center Consortium Sepsis Project Working Group. Epidemiology of sepsis syndrome in 8 academic medical centers. JAMA. 1997 Jul 16;278(3):234-40.
- Background: PubMed 16490136Tanriover MD, Guven GS, Sen D, Unal S, Uzun O. Epidemiology and outcome of sepsis in a tertiary-care hospital in a developing country. Epidemiol Infect. 2006 Apr;134(2):315-22. doi: 10.1017/S0950268805004978.
- Background: PubMed 10608764Gogos CA, Drosou E, Bassaris HP, Skoutelis A. Pro- versus anti-inflammatory cytokine profile in patients with severe sepsis: a marker for prognosis and future therapeutic options. J Infect Dis. 2000 Jan;181(1):176-80. doi: 10.1086/315214.
- BackgroundCavaillonJ-M.Pathophysiological role of pro-and anti-inflammatory cytokines in sepsis .Sepsis.1998;2(2):127-40.
- Background: PubMed 18274637Kurt AN, Aygun AD, Godekmerdan A, Kurt A, Dogan Y, Yilmaz E. Serum IL-1beta, IL-6, IL-8, and TNF-alpha levels in early diagnosis and management of neonatal sepsis. Mediators Inflamm. 2007;2007:31397. doi: 10.1155/2007/31397.
- Background: PubMed 15652449Oda S, Hirasawa H, Shiga H, Nakanishi K, Matsuda K, Nakamua M. Sequential measurement of IL-6 blood levels in patients with systemic inflammatory response syndrome (SIRS)/sepsis. Cytokine. 2005 Feb 21;29(4):169-75. doi: 10.1016/j.cyto.2004.10.010. Epub 2004 Dec 8.
- Background: PubMed 21445641Manzanares W, Biestro A, Torre MH, Galusso F, Facchin G, Hardy G. High-dose selenium reduces ventilator-associated pneumonia and illness severity in critically ill patients with systemic inflammation. Intensive Care Med. 2011 Jul;37(7):1120-7. doi: 10.1007/s00134-011-2212-6. Epub 2011 Mar 29.
- Background: PubMed 10816031Grossman RF, Fein A. Evidence-based assessment of diagnostic tests for ventilator-associated pneumonia. Executive summary. Chest. 2000 Apr;117(4 Suppl 2):177S-181S. doi: 10.1378/chest.117.4_suppl_2.177s. No abstract available.
- Background: PubMed 15699079American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
- Background: PubMed 9735080Cook DJ, Walter SD, Cook RJ, Griffith LE, Guyatt GH, Leasa D, Jaeschke RZ, Brun-Buisson C. Incidence of and risk factors for ventilator-associated pneumonia in critically ill patients. Ann Intern Med. 1998 Sep 15;129(6):433-40. doi: 10.7326/0003-4819-129-6-199809150-00002.
- Individual participant dataSharing planned: No. data that to be shared are age \& gender of the participants
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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.
Sara M. Shahen, MD study chair
Ain Shams University
Ibrahim E. Mamdoh, MD study chair
Ain Shams 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 Vitamin C in people with Ventilator Associated Pneumonia ( VAP) and Sepsis, run by Ain Shams 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 4 inclusion and 9 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 21 Jul 2020. 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?
The Incidence of Ventilator -Associated Pneumonia ( VAP) (time frame: within 28 days). The study lists 3 primary outcomes in all. 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 NCT04029675, which also lists 28 linked publications.
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 21 Jul 2020.