Table of Contents

• Trial overview
• Target patients and study setting
• Study design and phase
• Main endpoints being measured
• What the trial is meant to show

Trial overview

One authorised interventional study in the provided data is testing Sodium Ascorbate in patients with sepsis complicated by ARDS, which means a severe infection with serious lung failure.^[1]

This study is titled Lessening Organ Dysfunction with VITamin C in septic ARDS and is designed to compare high-dose intravenous vitamin C with placebo in ICU patients.^[1]

Target patients and study setting

The target population is patients with sepsis complicated by ARDS, and the brief summary says the study is in ICU patients.^[1]

ARDS stands for acute respiratory distress syndrome, which is a severe breathing problem that can happen during serious illness.^[1]

Study design and phase

This is an interventional trial, which means the researchers are giving a treatment and then measuring the results.^[1]

The trial is in Phase 3, which usually means the treatment is being tested in a larger group to better understand its effects and safety.^[1]

The planned enrollment is 814 participants, showing that this is a large study.^[1]

Main endpoints being measured

The primary outcome is death or persistent organ dysfunction at 28 days after treatment starts.^[1]

Persistent organ dysfunction is defined in the trial as continued need for mechanical ventilation, renal replacement therapy, or vasopressors.^[1]

Mechanical ventilation means breathing support from a machine, renal replacement therapy means treatment that helps the kidneys do their job, and vasopressors are medicines used to support blood pressure.^[1]

What the trial is meant to show

The study goal is to compare high-dose intravenous vitamin C, given as Sodium Ascorbate, against placebo in very ill ICU patients.^[1]

The trial is mainly trying to see whether the treatment can improve major short-term outcomes, especially survival and organ function at 28 days.^[1]

In the full dataset, other trials study different medicines and conditions, such as bowel cleansing, cancer, urinary tract infections, and bowel imaging, but those are not Sodium Ascorbate trials.^{[2][3][4][5][6][7][8][9][10]}