Ascorbate for Organ Dysfunction in Critically Ill Patients With Sepsis: The Phase 2b ASTER Trial
Abstract
Background: A phase 2 trial of high-dose IV ascorbate suggested reduced mortality in patients with ARDS, although trials in sepsis have failed to show clinical benefit.
Research question: Does IV high-dose ascorbate improve outcomes in patients with sepsis at risk of or with ARDS?
Study design and methods: In this phase 2b multicenter randomized placebo-controlled trial, patients with known or suspected infection and either shock or acute hypoxemic respiratory failure were randomized to ascorbate (50 mg/kg IV every 6 hours for 5 days) or a matching placebo. The primary outcome was days alive and free of respiratory, renal, and circulatory organ support to day 28. Secondary outcomes included clinical and biological end points.
Results: After enrolling 79 participants, the trial was terminated because of the publication of a separate study of septic shock reporting increased mortality with ascorbate. In the current study, days free of organ support were not different for patients receiving ascorbate compared with those receiving placebo: mean (SD), 20.5 (9.5) days vs 19.0 (10.8) days, respectively (P = .528). The 90-day all-cause mortality was 15% in the ascorbate group vs 33% in the placebo group (P = .057). This was 1 of 19 secondary end points. Soluble tumor necrosis factor receptor 1 levels were reduced in the ascorbate group vs placebo from baseline to both day 2 (median, -861 pg/mL [interquartile range (IQR), -3,043 to 128.9 pg/mL] vs 241.4 pg/mL [-820 to 1,671 pg/mL]; P…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 79 participants or records.
Read the paper
Related studies
- In silico toxicology protocols
- QM7-X, a comprehensive dataset of quantum-mechanical properties spanning the chemical space of small organic molecules
- Quantum Informed Machine-Learning Potentials for Molecular Dynamics Simulations of CO2's Chemisorption and Diffusion in Mg-MOF-74
- In-silico strategies in nano-drug design: Bridging nanomaterials and pharmacological applications
- mRNA codon optimization with quantum computers
- The computational power of the human brain
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.