Dataset Information

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.