Phase 3
Completed N=205
Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial
Sepsis · Septic Shock · Metabolic Disturbance
Source: ClinicalTrials.gov NCT03389555 ↗
Enrolled (actual)
205
Serious AEs
12.5%
Results posted
Jan 2021
Primary outcomePrimary: Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours — 9.1; 9.2; 4.4; 5.1 Units on a scale — p=0.12
◆ Published Evidence
Highly cited
248citations · ~41 / year
Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Organ Injury in Septic Shock: The ACTS Randomized Clinical Trial.
Summary
In this study, we aim to determine whether the combination of Ascorbic Acid (Vitamin C), Thiamine (Vitamin B1), and Corticosteroids improves the trajectory of organ failure and reduces mortality in patients with sepsis and septic shock as compared to placebo.
Linked Publications (3)
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Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Organ Injury in Septic Shock: The ACTS Randomized Clinical Trial.
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Ascorbic Acid, Corticosteroids and Thiamine in Sepsis (ACTS) protocol and statistical analysis plan: a prospective, multicentre, double-blind, randomised, placebo-controlled clinical trial.
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Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Health-Related Quality of Life in Sepsis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours |
9.1; 9.2; 4.4; 5.1 | 0.12 |
| SECONDARY Renal Failure |
32; 27 | 0.58 |
| SECONDARY 30-day Mortality |
35; 29 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- Adult patient (age ≥ 18 years)
- Suspected (cultures drawn and antibiotic given) or confirmed (via culture results) infection
- Receiving vasopressor (norepinephrine, phenylephrine, epinephrine, dopamine, angiotensin II or vasopressin)
Exclusion Criteria
- Member of a protected population (pregnant, prisoner)
- Known kidney stones within the past 1 year (except for asymptomatic, incidentally noted stones on imaging)
- End stage renal disease (ESRD) requiring dialysis
- Known Glucose-6-Phosphate Dehydrogenase deficiency
- Known Hemachromatosis
- Comfort Measures Only status
- Anticipated death within 24-hours despite maximal therapy (as determined by the enrolling physician)
- Receiving supplemental thiamine in a dose greater than that contained in a multivitamin
- Clinical indication for steroids (e.g. chronic use) as determined by the clinical team providing this drug
- Clinical indication for thiamine as determined by the clinical team providing this drug
- Clinical indication for ascorbic acid as determined by the clinical team providing this drug
- Known allergy to vitamin C, hydrocortisone, or thiamine
Data sourced from ClinicalTrials.gov (NCT03389555) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.