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Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial

NCT03389555 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2021-02-16

Study results available
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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.

Conditions

  • Sepsis
  • Septic Shock
  • Metabolic Disturbance

Interventions

DRUG

vitamin C, vitamin B1, hydrocortisone

Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9% NACL(normal saline) and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.

DRUG

Normal saline

Normal saline (0.9% NaCl solution) volume to match all components

Sponsors & Collaborators

Principal Investigators

  • Michael W Donnino, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2019-11-26
Completion
2020-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03389555 on ClinicalTrials.gov