Dataset Information

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.

ABSTRACT:

Importance

Experimental data suggest that intravenous vitamin C may attenuate inflammation and vascular injury associated with sepsis and acute respiratory distress syndrome (ARDS).

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.

Design, setting, and participants

The CITRIS-ALI trial was a randomized, double-blind, placebo-controlled, multicenter trial conducted in 7 medical intensive care units in the United States, enrolling patients (N?=?167) with sepsis and ARDS present for less than 24 hours. The study was conducted from September 2014 to November 2017, and final follow-up was January 2018.

Interventions

Patients were randomly assigned to receive intravenous infusion of vitamin C (50 mg/kg in dextrose 5% in water, n?=?84) or placebo (dextrose 5% in water only, n?=?83) every 6 hours for 96 hours.

Main outcomes and measures

The primary outcomes were 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.

Results

Among 167 randomized patients (mean [SD] age, 54.8 years [16.7]; 90 men [54%]), 103 (62%) completed the study to day 60. There were no significant differences between the vitamin C and placebo groups in the primary end points of change in mean modified Sequential Organ Failure Assessment score from baseline to 96 hours (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]; difference, -0.10; 95% CI, -1.23 to 1.03; P?=?.86) or in C-reactive protein levels (54.1 vs 46.1 ?g/mL; difference, 7.94 ?g/mL; 95% CI, -8.2 to 24.11; P?=?.33) and thrombomodulin levels (14.5 vs 13.8 ng/mL; difference, 0.69 ng/mL; 95% CI, -2.8 to 4.2; P?=?.70) at 168 hours.

Conclusions and relevance

In this preliminary study of patients with sepsis and ARDS, a 96-hour infusion of vitamin C compared with placebo did not significantly improve organ dysfunction scores or alter markers of inflammation and vascular injury. Further research is needed to evaluate the potential role of vitamin C for other outcomes in sepsis and ARDS.

Trial registration

ClinicalTrials.gov Identifier: NCT02106975.

SUBMITTER: Fowler AA

PROVIDER: S-EPMC6777268 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Fowler Alpha A AA Truwit Jonathon D JD Hite R Duncan RD Morris Peter E PE DeWilde Christine C Priday Anna A Fisher Bernard B Thacker Leroy R LR Natarajan Ramesh R Brophy Donald F DF Sculthorpe Robin R Nanchal Rahul R Syed Aamer A Sturgill Jamie J Martin Greg S GS Sevransky Jonathan J Kashiouris Markos M Hamman Stella S Egan Katherine F KF Hastings Andrei A Spencer Wendy W Tench Shawnda S Mehkri Omar O Bindas James J Duggal Abhijit A Graf Jeanette J Zellner Stephanie S Yanny Lynda L McPolin Catherine C Hollrith Tonya T Kramer David D Ojielo Charles C Damm Tessa T Cassity Evan E Wieliczko Aleksandra A Halquist Matthew M

JAMA 20191001 13

<h4>Importance</h4>Experimental data suggest that intravenous vitamin C may attenuate inflammation and vascular injury associated with sepsis and acute respiratory distress syndrome (ARDS).<h4>Objective</h4>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.<h4>Design, setting, and participants</h4>The CITRIS-ALI trial was a randomized, double-blind, placebo-controlled, mult ...[more]

PMID: 31573637

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Dataset Information

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.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

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.

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