Sepsis Treatment With Vitamin C And Thiamine
Brief Summary:
Acute respiratory failure due to COVİD-19 pneumonia has poor prognosis and high mortality . Both the lack of an effective antiviral treatment and the low level evidence of the recommendations presented in the guidelines on other treatment methods have highlighted supportive treatments. Studies suggest that high-dose vitamin C treatment reduces mortality in patients with sepsis and ARDS, and may also be beneficial in COVİD-19 disease. In the study; the investigator aimed to determine the effect of Vitamin C on short-term mortality and length of intensive care stay in COVID-19 patients.
| Condition or disease | Intervention/treatment |
|---|---|
| Respiratory Distress Syndrome, Adult Covid19 | Drug: Ascorbic acid |
Detailed Description:
SARS-CoV-2 causes tissue damage in the endothelium and epithelium, increased vascular permeability and increased plasma levels of IL-6, IL-2, IL-7, IL-10 causing interstitial fibrosis in the lung is considered. Considering these factors in pathogenesis, a picture with high mortality from acute respiratory failure to severe ARDS emerges in critically ill COVID-19 patients. However, despite numerous studies, an effective antiviral treatment has not yet been found in COVID-19 disease. The low level of evidence for the recommendations presented in the guidelines on both treatment and mechanical ventilation has brought supportive treatments to the agenda. Recently, many articles have been published on the potential effects of anti-inflammatory and antioxidant treatments such as high-dose vitamin C, vitamin D, zinc and ozone therapy. In particular, high-dose intravenous vitamin C treatment is inexpensive, easily accessible, and it reduces mortality in patients with sepsis and ARDS in studies, suggesting that it may be beneficial in COVID-19 disease. this is a retrospective cohort study. The main goal of the study; to compare patients who did not receive high-dose vitamin C treatment in the first period of the epidemic and those who received treatment in the next period. the investigator aimed to determine the effect of Vitamin C on short-term mortality and length of stay in intensive care in critically ill COVID-19 patients. All patients' data on age, gender, body mass index, comorbidities (diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, other), PaO2 / FiO2 ratios, SOFA scores, ferritin, C-Reactive Protein, procalcitonin, lactate, neutrophil and lymphocyte values will be collected by scanning the hospital information system.
| Study Type : | Observational |
| Actual Enrollment : | 78 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | High-Dose Vitamin C Treatment in Critically Ill COVID-19 Patients, A Retrospective Cohort Study |
| Actual Study Start Date : | January 16, 2021 |
| Actual Primary Completion Date : | January 25, 2021 |
| Actual Study Completion Date : | February 10, 2021 |
Resource links provided by the National Library of Medicine 
| Group/Cohort | Intervention/treatment |
|---|---|
| C Vit The patients who were admitted to the intensive care unit and received a high dose intravenous vitamin C protocol constituted the treatment group | Drug: Ascorbic acid The daily administration of 6 grams of vitamin C intravenously in 4 equal doses every 6 hours occurred and the treatment lasted 96 hours. Vials containing 1.5 gr vitamin C were placed in 100 cc 5% dextrose and infused intravenously in 30-60 minutes. Prepared serum bottles and sets are wrapped with aluminum foil in order to protect them from sunlight. |
| non-C Vit The patients who were admitted to the intensive care unit but did not receive the vitamin C protocol constituted the control group | Drug: Ascorbic acid The daily administration of 6 grams of vitamin C intravenously in 4 equal doses every 6 hours occurred and the treatment lasted 96 hours. Vials containing 1.5 gr vitamin C were placed in 100 cc 5% dextrose and infused intravenously in 30-60 minutes. Prepared serum bottles and sets are wrapped with aluminum foil in order to protect them from sunlight. |
Primary Outcome Measures :
- short term mortality [ Time Frame: days 1-28 ]
Incidence of mortality at 28 days by all causes
- Length of Intensive Care Unit Stay [ Time Frame: up to 28 days ]
Length of Intensive Care Unit Stay
Secondary Outcome Measures :
- vasopressor requirement [ Time Frame: 1-28 days ]
all types of vasopressor requirement in intensive care stay
- invasive mechanical ventilation requirement [ Time Frame: 1-28 days ]
invasive mechanical ventilation requirement
- PaO2/FiO2 ratio [ Time Frame: 1-4 day ]
Change in PaO2/FiO2 ratio from admission to 4th day
- C-reactive protein [ Time Frame: 1-4 days ]
Change in C-reactive protein from admission to 4th day
- procalcitonin [ Time Frame: 1-4 days ]
Change in procalcitonin from admission to 4th day
- Lymphocyte count [ Time Frame: 1-4 days ]
Change in Lymphocyte count from admission to 4th day
- ferritin [ Time Frame: 1-4 days ]
Change in ferritin from admission to 4th day
- SOFA [ Time Frame: 1-4 days ]
Change in Sequential Organ Failure Assessment score from admission to 4th day.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
patients who admitted to the intensive care unit with the diagnosis of acute respiratory failure due to COVID-19 pneumonia
Inclusion Criteria:
- Hospitalized with diagnosis of COVID-19, diagnosis confirmed by PCR test
- pneumonia due to COVID-19 was diagnosed with clinical and radiological findings
- Patients who developed acute respiratory failure (PaO2 / FiO2 300 despite the use of 6 l / min reservoir mask) caused by COVID-19 pneumonia
- Older than 18 year
Exclusion Criteria:
- Renal failure
- Hepatic failure
- End-stage malignity
- Primary lung disease (lung cancer, cardio-pulmonary edema)
- Patients who treated with tocilizumab
- Presence of diabetic ketoacidosis, use of insulin infusion, or frequent need for point-of-care glucose monitoring (>6 times/24 hour period) as determined by treating physician
- Active kidney stone
- patients with hospitalization in ICU less than 96 hours
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): NCT04710329
| Turkey | |
| Sisli etfal training and resource hospital | |
| Sisli, İstanbul, Turkey, 34376 | |
Sisli Hamidiye Etfal Training and Research Hospital
| Study Chair: | Surhan Çınar | Sisli etflal resource and training hospital |
Fowler AA 3rd, Truwit JD, Hite RD, Morris PE, DeWilde C, Priday A, Fisher B, Thacker LR 2nd, Natarajan R, Brophy DF, Sculthorpe R, Nanchal R, Syed A, Sturgill J, Martin GS, Sevransky J, Kashiouris M, Hamman S, Egan KF, Hastings A, Spencer W, Tench S, Mehkri O, Bindas J, Duggal A, Graf J, Zellner S, Yanny L, McPolin C, Hollrith T, Kramer D, Ojielo C, Damm T, Cassity E, Wieliczko A, Halquist M. Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial. JAMA. 2019 Oct 1;322(13):1261-1270. doi: 10.1001/jama.2019.11825. Erratum in: JAMA. 2020 Jan 28;323(4):379.
Kim WY, Jo EJ, Eom JS, Mok J, Kim MH, Kim KU, Park HK, Lee MK, Lee K. Combined vitamin C, hydrocortisone, and thiamine therapy for patients with severe pneumonia who were admitted to the intensive care unit: Propensity score-based analysis of a before-after cohort study. J Crit Care. 2018 Oct;47:211-218. doi: 10.1016/j.jcrc.2018.07.004. Epub 2018 Jul 5.
Moskowitz A, Huang DT, Hou PC, Gong J, Doshi PB, Grossestreuer AV, Andersen LW, Ngo L, Sherwin RL, Berg KM, Chase M, Cocchi MN, McCannon JB, Hershey M, Hilewitz A, Korotun M, Becker LB, Otero RM, Uduman J, Sen A, Donnino MW; ACTS Clinical Trial Investigators. Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Organ Injury in Septic Shock: The ACTS Randomized Clinical Trial. JAMA. 2020 Aug 18;324(7):642-650. doi: 10.1001/jama.2020.11946.
| Responsible Party: | nurcan coskun, specialist medical doctor, Sisli Hamidiye Etfal Training and Research Hospital |
| ClinicalTrials.gov Identifier: | NCT04710329 |
| Other Study ID Numbers: | CVIT-3334 |
| First Posted: | January 14, 2021 Key Record Dates |
| Last Update Posted: | February 15, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by nurcan coskun, Sisli Hamidiye Etfal Training and Research Hospital:
| coronavirus disease 2019 Ascorbic Acid intensive care |
Additional relevant MeSH terms:
| COVID-19 Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections | Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury Ascorbic Acid Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Vitamins Micronutrients |
Sepsis Treatment With Vitamin C And Thiamine
Source: https://www.clinicaltrials.gov/ct2/show/NCT04710329
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