scholarly journals Early high-dose vitamin C in post-cardiac arrest syndrome (VITaCCA): study protocol for a randomized, double-blind, multi-center, placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sander Rozemeijer ◽  
Harm-Jan de Grooth ◽  
Paul W. G. Elbers ◽  
Armand R. J. Girbes ◽  
Corstiaan A. den Uil ◽  
...  
Keyword(s):  
Cardiac Arrest ◽  
Vitamin C ◽  
Organ Failure ◽  
Controlled Trial ◽  
Lung Injury Score ◽  
High Dose ◽  
Double Blind ◽  
Link Type ◽  
Search Trial ◽  
Intravenous Vitamin

Abstract Background High-dose intravenous vitamin C directly scavenges and decreases the production of harmful reactive oxygen species (ROS) generated during ischemia/reperfusion after a cardiac arrest. The aim of this study is to investigate whether short-term treatment with a supplementary or very high-dose intravenous vitamin C reduces organ failure in post-cardiac arrest patients. Methods This is a double-blind, multi-center, randomized placebo-controlled trial conducted in 7 intensive care units (ICUs) in The Netherlands. A total of 270 patients with cardiac arrest and return of spontaneous circulation will be randomly assigned to three groups of 90 patients (1:1:1 ratio, stratified by site and age). Patients will intravenously receive a placebo, a supplementation dose of 3 g of vitamin C or a pharmacological dose of 10 g of vitamin C per day for 96 h. The primary endpoint is organ failure at 96 h as measured by the Resuscitation-Sequential Organ Failure Assessment (R-SOFA) score at 96 h minus the baseline score (delta R-SOFA). Secondary endpoints are a neurological outcome, mortality, length of ICU and hospital stay, myocardial injury, vasopressor support, lung injury score, ventilator-free days, renal function, ICU-acquired weakness, delirium, oxidative stress parameters, and plasma vitamin C concentrations. Discussion Vitamin C supplementation is safe and preclinical studies have shown beneficial effects of high-dose IV vitamin C in cardiac arrest models. This is the first RCT to assess the clinical effect of intravenous vitamin C on organ dysfunction in critically ill patients after cardiac arrest. Trial registration ClinicalTrials.gov NCT03509662. Registered on April 26, 2018. https://clinicaltrials.gov/ct2/show/NCT03509662European Clinical Trials Database (EudraCT): 2017-004318-25. Registered on June 8, 2018. https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-004318-25/NL

scholarly journals A Pilot, Double-Blind, Randomized, Controlled Trial of High-Dose Intravenous Vitamin C for Vasoplegia After Cardiac Surgery

2020 ◽  
Vol 34 (2) ◽  
pp. 409-416 ◽  
Author(s):  
Fumitaka Yanase ◽  
Laurent Bitker ◽  
Lara Hessels ◽  
Eduardo Osawa ◽  
Thummaporn Naorungroj ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Surgery ◽  
Vitamin C ◽  
Controlled Trial ◽  
High Dose ◽  
Double Blind ◽  
Randomized Controlled ◽  
Intravenous Vitamin

scholarly journals High dose vitamin C in sepsis (HDVCIS): study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Bing Zhao ◽  
Mengjiao Li ◽  
Jian Li ◽  
Leshan Liu ◽  
Yihui Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin C ◽  
Animal Studies ◽  
Controlled Trial ◽  
Small Scale ◽  
Controlled Clinical Trial ◽  
High Dose ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
High Dose Vitamin

Abstract Sepsis is an inflammatory syndrome with life-threatening organ dysfunction resulting from a dysregulated host response to infection. Although the treatment for sepsis has improved a lot in the last 30 years, sepsis related mortality remains high. In the recent 10 years, high dose intravenous injection of vitamin C, the first line antioxidant of human, has received more and more attention in the field of critical care, its beneficial effect has been demonstrated by several small scale clinical trial and animal studies, but the effect of high dose vitamin C on sepsis in a larger trial seems warranted in further study. Here we will conduct a prospective, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial named as HDVCIS. The trial protocol has been approved by Clinical Trail Ethics Committee of Ruijin Hospital of Shanghai JiaoTong University School of Medicine. This trial has been registered in Chinese Clinical Trial Registry (ChiCTR1800017633) in August 7, 2018. Patients will be recruited from 4 medical centers in China. Its object is to testify the efficacy and safety of high dose vitamin C in the treatment of sepsis.

scholarly journals Impact of High-Dose Intravenous Vitamin C on Cell-Free DNA and Syndecan-1 in Patients with Sepsis-Associated ARDS

2021 ◽  
Author(s):  
Markos G. Kashiouris
Keyword(s):  
Vitamin C ◽  
Plasma Cell ◽  
Controlled Trial ◽  
Neutrophil Extracellular Trap ◽  
Endothelial Glycocalyx ◽  
High Dose ◽  
Cell Free Dna ◽  
Free Dna ◽  
Intravenous Vitamin ◽  
Post Hoc

Abstract Background:We set out to examine the effects of high dosage intravenous vitamin C (HDIVC) infusion on plasma cell-free DNA and Syndecan-1, two mortality biomarkers that represent neutrophil extracellular trap (NET) formation and degradation of the endothelial glycocalyx.Methods: Post-hoc analysis of plasma cell-free DNA and syndecan-1 in patients enrolled in the randomized placebo-controlled trial: Vitamin C Infusion for Treatment in Sepsis-Induced Acute Lung Injury, the CITRIS-ALI trial. Setting: Seven intensive care units in hospitals located in five different states in the U.S. Patients: Septic adults with ARDS between September 2014 to November 2017, final follow-up January 2018.Results: In 167 study patients, baseline plasma cfDNA levels in HDIVC (84 patients) and placebo (83 patients) were 2.18 ng/µL (SD 4.20 ng/µL) and 2.65 ng/µL (SD 3.87 ng/µL), respectively, p=0.45. At 48-hours, the cfDNA reduction was 1.02 ng/µL greater in HDIVC, compared to placebo, p=0.05. Mean baseline plasma syndecan-1 levels in HDIVC and placebo were 9.49 ng/mL (SD 5.57 ng/mL) and 10.83 ng/mL (SD 5.95 ng/mL) respectively, p=0.14. At 48 hours, patients in the placebo arm exhibited a 1.53 ng/mL (95% CI, 0.96 to 2.11) increase in syndecan-1 vs. 0.75 ng/mL (95% CI, 0.21 to 1.29), in HDIVC patients, p=0.05. The 48-hour plasma syndecan-1 levels in patients treated with HDIVC exhibited a linear association with improved oxygenation (PaO2/FiO2, beta= -18.9, p=0.004).Conclusions:HDIVC infusion significantly attenuated plasma cell-free DNA and syndecan-1, biomarkers known to be elevated in sepsis-induced ARDS. These results support the conclusion that high dosage intravenous vitamin C infusion reduces sepsis-induced vascular injury.Trial Registration: ClinicalTrials.gov identifier: NCT02106975

scholarly journals Intravenous Vitamin C administration reduces fatigue in office workers: a double-blind randomized controlled trial

2012 ◽  
Vol 11 (1) ◽  
Author(s):  
Sang-Yeon Suh ◽  
Woo Kyung Bae ◽  
Hong-Yup Ahn ◽  
Sung-Eun Choi ◽  
Gyou-Chul Jung ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Vitamin C ◽  
Controlled Trial ◽  
Office Workers ◽  
Double Blind ◽  
Randomized Controlled ◽  
Intravenous Vitamin

scholarly journals Effect of High-Dose Intravenous Vitamin C on Postpartum Oxidative Stress in Severe Preeclampsia

2020 ◽  
Vol 1 (2) ◽  
pp. 122-131
Author(s):  
Monika Korenc ◽  
Joško Osredkar ◽  
Ksenija Gersak ◽  
Kristina Kumer ◽  
Teja Fabjan ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Placebo Group ◽  
Vitamin C ◽  
Controlled Trial ◽  
Study Groups ◽  
Severe Preeclampsia ◽  
High Dose ◽  
Oxidative Stress Biomarkers ◽  
Intravenous Vitamin ◽  
Singleton Pregnancies

Purpose: To determine whether high-dose intravenous vitamin C reduces oxidative stress in patients with severe preeclampsia in the first days postpartum. Methods: Biomarkers of oxidative stress were assessed as secondary outcomes of a single-center, randomized, placebo-controlled trial. Thirty-four patients with singleton pregnancies complicated by severe features of preeclampsia were randomized into two groups: intravenous vitamin C (1.5 g/6 h) (n = 17) or placebo (n = 17). Urinary concentrations of dityrosine, 8-hydroxy-2-deoxyguanosine (8-OHdg), 8-isoprostane, and N epsilon-(hexanoyl) lysine (HEL) were measured at days one and three after delivery and normalized for urinary creatinine in 22 of patients included (12 in vitamin C and 10 in placebo group). The Mann–Whitney U-test was used to compare values of oxidative stress biomarkers at days one and three after delivery in vitamin C vs. placebo groups (p ≤ 0.05 significant). Results: Dityrosine and 8-OHdg values did not differ significantly between the two study groups at day one after delivery (p = 0.23 and p = 0.77, respectively), but were significantly lower in the vitamin C group compared to the placebo group at day three after delivery (p = 0.04 and p = 0.03, respectively). Values of 8-isoprostane and HEL did not differ significantly between the two study groups at day one (p = 0.41 and p = 0.42, respectively), as well as at day three, after delivery (p = 0.25 and p = 0.24, respectively). Conclusion: High-dose intravenous vitamin C treatments in patients with severe preeclampsia reduced urinary levels of dityrosine and 8-OHdg (markers of protein and DNA oxidative damage, respectively) on day three after delivery. Vitamin C treatment had no significant effect on lipid peroxidation biomarkers, i.e., 8-isoprostane and HEL.

scholarly journals Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Marie-Hélène Masse ◽  
◽  
Julie Ménard ◽  
Sheila Sprague ◽  
Marie-Claude Battista ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Vitamin C ◽  
Organ Dysfunction ◽  
Controlled Trial ◽  
Invasive Mechanical Ventilation ◽  
Kidney Injury ◽  
Composite Endpoint ◽  
High Dose ◽  
Randomized Controlled ◽  
Intravenous Vitamin

Abstract Background Sepsis is a health problem of global importance; treatments focus on controlling infection and supporting failing organs. Recent clinical research suggests that intravenous vitamin C may decrease mortality in sepsis. We have designed a randomized controlled trial (RCT) to ascertain the effect of vitamin C on the composite endpoint of death or persistent organ dysfunction at 28 days in patients with sepsis. Methods LOVIT (Lessening Organ dysfunction with VITamin C) is a multicenter, parallel-group, blinded (participants, clinicians, study personnel, Steering Committee members, data analysts), superiority RCT (minimum n = 800). Eligible patients have sepsis as the diagnosis for admission to the intensive care unit (ICU) and are receiving vasopressors. Those admitted to the ICU for more than 24 h are excluded. Eligible patients are randomized to high-dose intravenous vitamin C (50 mg/kg every 6 h for 96 h) or placebo. The primary outcome is a composite of death or persistent organ dysfunction (need for vasopressors, invasive mechanical ventilation, or new and persisting renal replacement therapy) at day 28. Secondary outcomes include persistent organ dysfunction-free days to day 28, mortality and health-related quality of life at 6 months, biomarkers of dysoxia, inflammation, infection, endothelial function, and adverse effects (hemolysis, acute kidney injury, and hypoglycemia). Six subgroup analyses are planned. Discussion This RCT will provide evidence of the effect of high-dose intravenous vitamin C on patient-important outcomes in patients with sepsis. Trial registration clinicaltrials.gov, NCT03680274, first posted 21 September 2018.

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