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The CITRIS-ALI Randomized Clinical Trial PowerPoint Presentation

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Description : Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure.

Tags : Ascorbic acid, cancer management, intravenous vitamin C infusion

Published on : Nov 17, 2020 | Views : 1344 | Downloads : 1

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Critical Appraisal 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 Alpha A Fowler 3rd, Jonathon D Truwit, R Duncan Hite, Peter E Morris, Christine DeWilde, Anna Priday et al.
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Background Ascorbic acid was identified in the 1920’s and since then proponents have advocated for its use as an adjunct in the management of clinical entities from the common cold to cancer management. In 2017, Marik et al, published a retrospective before-after study of (N=94) that demonstrated a major mortality benefit (ARR 31.9%), and no harms associated with the use of what has come to be known as the “Marik cocktail” which includes Vitamin C, hydrocortisone and thiamine. Since then three publications (Litwak, Mitchell,) with enrollments ranging from 94-167 patients have reported negative primary outcome measures.
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Objective To determine the effect of intravenous vitamin C infusion on organ failure scores and biological markers of inflammation and vascular injury in patients with sepsis and ARDS.”
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PICO P: Patients With Sepsis and Severe Acute Respiratory Failure. I: Vitamin C infusion every 6 hours for 96 hours. C: Placebo (dextrose 5% in water alone) every 6 hours for 96 hours. O: Change in organ failure as assessed by a mSOFA score from baseline to 96 hours, and plasma biomarkers of inflammation and vascular injury.
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Inclusion criteria All criteria had to be met within a 24-hour period. On mechanical ventilation through an endotracheal tube. PaO2 to FiO2 ratio less than 300 mm Hg. Bilateral opacities on CXR within 1 week of known clinical insult. New or worsening respiratory symptoms. Suspected or proven infection. Met 2 of 4 SIRS.
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Exclusion criteria Known allergy to vitamin C No ability to obtain informed consent. Younger than 18 years. Non-English speaking. Pregnant or breastfeeding. Moribund and not expected to survive 24 hours. Required home mechanical ventilation. Receiving home oxygen greater than 2 L/min. Interstitial lung disease, diffuse alveolar hemorrhage, diabetic ketoacidosis, or an active kidney stone.
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Primary outcome Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-20, with higher scores indicating more dysfunction) from baseline to 96 hours, and plasma biomarkers of inflammation (C-reactive protein levels) and vascular injury (thrombomodulin levels) measured at 0, 48, 96, and 168 hours.
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Secondary outcome All-cause mortality at day 28. Ventilator-free days to day 28 ICU-free days to day 28. Hospital-free days at day 60.
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Relevance
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Validity Randomization
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Validity Concealment
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Validity Blinding
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Validity Were the groups similar at the start of the trial?
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Validity Were the groups treated equally?
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Validity Were all patients who entered the trial accounted for and attributed at its conclusion?
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Validity Were all clinically important outcomes considered?
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Validity Were all clinically important outcomes considered?
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Validity Were all clinically important outcomes considered?
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Results
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Results (all-causes mortality) ARR= CER - EER =38/84 – 27/86 = 0.452 – 0.314 = 0.138 RRR = ARR / CER = 0.138/0.452 = 0.3 NNT= 1/ARR = 1/0.138 = 7.2
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Results How precise was the estimated treatment effect at a 95% confidence interval? Primary: The mean mSOFA score from baseline to 96 hours decreased from 9.8 to 6.8 in the vitamin C group (3 points) and from 10.3 to 6.8 in the placebo group (3.5 points) (95% CI, −1.23 to 1.03; P = 0.86). There were no significant differences between the vitamin C group and placebo group in the C-reactive protein levels (54.1 vs 46.1 μg/mL; difference, 7.94; 95% CI, −8.23 to 24.1; P = 0.33) or thrombomodulin levels (14.5 vs 13.8 ng/mL; difference, 0.69; 95% CI, −2.8 to 4.2; P = 0.70) assessed at 168 hours.
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Results How precise was the estimated treatment effect at a 95% confidence interval? Secondary: Mortality was 45.2% (38/84) in the placebo group vs 31.4% (27/86) in the vitamin C group, ARR 13.8% [95% CI, 2% to 31.1%] P=0.03 ICU-free days to day 28 was 10.7% in the vitamin C group vs 7.7% in the placebo group, ARR 3.2%; [95%CI, 0.3 to 5.9]; P = 0.03 The number of hospital-free days in the vitamin C group vs the placebo group was 22.6% vs 15.5%, ARR 6.69% [95%CI,0.3 to 13.8] P = 0.04
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Applicability Is your Patient is similar to the population of the study? Yes
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Applicability Can you do the Intervention exactly as it is described in the paper? Yes, (All-Causes Mortality)
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Limitation CITRIS-ALI enrollment required fully developed ARDS with endotracheal intubation (Delay). Secondary analysis did not adjust for multiple comparisons. Differences in baseline characteristics. Vitamin C dose.
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Thank You