In short
Clinical trials investigating Sodium Ascorbate are studying how it performs in different patient groups, mainly in hospital and intensive care settings. The trials focus on safety, effectiveness, and clinical outcomes such as organ function, survival, or recovery. Some studies also include patients with cancer or severe infection.
Key points
- Sodium Ascorbate is being studied in a Phase 3 clinical trial for patients with sepsis complicated by ARDS, which is a severe infection with serious lung failure. The trial is testing whether it can improve major outcomes in ICU patients. The main outcome is death or persistent organ dysfunction at 28 days. Persistent organ dysfunction means the patient still needs support such as a ventilator, dialysis, or vasopressors. The study is authorised and plans to enroll 814 participants.
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.
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.
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.
ARDS stands for acute respiratory distress syndrome, which is a severe breathing problem that can happen during serious illness.
Study design and phase
This is an interventional trial, which means the researchers are giving a treatment and then measuring the results.
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.
The planned enrollment is 814 participants, showing that this is a large study.
Main endpoints being measured
The primary outcome is death or persistent organ dysfunction at 28 days after treatment starts.
Persistent organ dysfunction is defined in the trial as continued need for mechanical ventilation, renal replacement therapy, or vasopressors.
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.
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.
The trial is mainly trying to see whether the treatment can improve major short-term outcomes, especially survival and organ function at 28 days.
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.