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Steroids, Thiamine and Ascorbic Acid in Septic Shock

NCT04134403 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-10-22

No results posted yet for this study

Summary

The objective of this project is to determine if in patients admitted to the hospital with septic shock (population), does treatment with a bundle including hydrocortisone, thiamine, and ascorbic acid improve in-hospital or 28-day mortality (primary outcomes) or surrogate markers of illness severity including: (1) ICU or hospital length-of-stay, (2) duration of invasive mechanical ventilation, (3) duration of vasopressor administration, (4) incidence and severity of ICU delirium, and (5) illness severity (secondary outcomes).

Conditions

  • Septic Shock

Interventions

DRUG

STASIS

Hydrocortisone sodium succinate, 50 mg, every 6 hours, 7 days or until ICU discharge Thiamine, 200 mg, every 12 hours, 4 days or until ICU discharge Ascorbic acid, 1,500 mg, every 6 hours, 4 days or until ICU discharge

Sponsors & Collaborators

  • Hamadan University of Medical Science

    collaborator OTHER

  • Tehran University of Medical Sciences

    collaborator OTHER

  • Baqiyatallah Medical Sciences University

    lead OTHER

Principal Investigators

  • Amir Vahedian-Azimi, PhD · Baqiyatallah University of Medical Scienecs

  • Andrew C Miller, MD · East Carolina University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2020-11-01
Completion
2020-12-01

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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 NCT04134403 on ClinicalTrials.gov