Steroids, Thiamine and Ascorbic Acid in Septic Shock

NCT04134403 | Unknown Phase 3 DMC

• 1 other identifier: STASIS
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Steroids; Thiamine; Ascorbic Acid Supplementation; Septic Shock; STASIS

Outcome Measures

Primary Outcomes (1)

• In-hospital or 28-day mortality rate

  To determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care versus standard care in septic shock confers an in-hospital and 28-day mortality benefit

  28 days or discharge (whichever comes first)

Secondary Outcomes (10)

• Illness Severity (Change in SOFA Score)

  72 hours

• Hospital length-of-stay ICU LOS Duration of intubation

  1 year or discharge (whichever comes first)

• ICU length-of-stay

  90 days or discharge (whichever comes first)

• Vasopressor duration (days)

  28 days or discharge (whichever comes first)

• ICU delerium (CAM-ICU score)

  28 days or discharge (whichever comes first)

Study Arms (2)

Arm 1: Intervention

EXPERIMENTAL

Arm will be those that are randomized to receive usual care plus hydrocortisone, thiamine and ascorbic acid.

Drug: STASIS

Arm 2: Usual care

NO INTERVENTION

Arm will be those that are randomized to receive usual care alone.

Interventions

STASIS DRUG

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

Arm 1: Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Septic shock admitted to the ICU within 24 hours as defined by SEPSIS-3
• SEPSIS-3 defines septic shock as sepsis with the following criteria despite adequate fluid resuscitation:
• Vasopressor required to maintain MAP ≥ 65 AND
• Serum lactate level \>2.0 mmol/L
• Age ≥ 18 years
• Non-pregnant
• Ability to consent with medical capacity or legally authorized representative (LAR) consent

You may not qualify if:

• Age \< 18 years
• Pregnant defined by negative serum HCG in all females
• Patients with limitation of care (i.e. DNR)
• Known G6PD deficiency
• Excluding primary admission diagnosis including the following:
• Acute stroke
• Acute coronary syndrome
• Active gastrointestinal bleed
• Burn
• Trauma
• Prisoners
• \>1 episode of sepsis in hospital admission
• Vasopressor use prior to randomization for more than 24 hours

Sponsors & Collaborators

• Baqiyatallah Medical Sciences University: lead
• Hamadan University of Medical Science: collaborator
• Tehran University of Medical Sciences: collaborator

MeSH Terms

Conditions

Shock, Septic

Interventions

IbsC protein, E coli

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Amir Vahedian-Azimi, PhD

  Baqiyatallah University of Medical Scienecs

  PRINCIPAL INVESTIGATOR

• Andrew C Miller, MD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amir Vahedian-Azimi, PhD

CONTACT

+98 919 6017 138; amirvahedian63@gmail.com

Andrew C Miller, MD

CONTACT

Taqwa1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Associate Professor

Model Details: A Prospective Parallel Randomized Controlled clinical Study

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: October 22, 2019
• Study Start: December 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share