Thiamine, Vitamin C and Hydrocortisone in the Treatment of Septic Shock

NCT03540628 | Completed

• 1 other identifier: MMMC#1576
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine whether patients who receive thiamine (vitamin B1), vitamin C and hydrocortisone while in septic shock have improved outcomes compared to hydrocortisone alone. A recently published article "Hydrocortisone, Vitamin C and Thiamine for the treatment of Severe Sepsis and Septic Shock," suggested substantial mortality reduction (78%). We wish to test the hypothesis that mortality reduction is at least 25% in a prospective randomized trial. Other important sub-aims include the testing whether the protocol reduces the time on pressors agents, reduces the trajectory of the SOFA score, or reduces the trajectory of procalcitonin.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• The mortality rate comparison of patients with septic shock at Lakeland Regional Medical Center to the study published in CHEST.

  The mortality rate difference between control and experimental arms

  24 months

Secondary Outcomes (2)

• The duration on vasopressor support

  24 months

• Quantify the Sequential Organ Failure Assessment score in Septic shock patients requiring vasopressor therapy

  24 months

Study Arms (2)

Placebo Arm

NO INTERVENTION

The control arm of our randomized trial will receive a second pressor agent, hydrocortisone and standard of care to care for septic shock. The IV bags will be blinded by pharmacy. If the patient needs additional pressor support or therapy, the data will be recorded in the results.

Thiamine and Vitamin C administration Arm

EXPERIMENTAL

The experimental arm will receive a second pressor agent and hydrocortisone, plus thiamine and vitamin C along with the standard of care. The IV bags will be blinded by pharmacy. If the patient needs additional pressor support or therapy, the data will be recorded in the results.

Dietary Supplement: Thiamine and Vitamin C

Interventions

Thiamine and Vitamin C DIETARY_SUPPLEMENT

Supplementary vitamins for the patient in septic shock

Thiamine and Vitamin C administration Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Septic Shock on two vasopressor agents
• Age between 18-90 years old
• Ability to provide written informed consent

You may not qualify if:

• Age younger than 18 years old
• Pregnancy
• DNR or DNI status with limitations of care, such as "supportive care only"
• Patients/advocates that request thiamine, vitamin C or hydrocortisone supplementation

Sponsors & Collaborators

• Corewell Health South: lead

Study Sites (1)

Lakeland Regional Healthcare

Saint Joseph, Michigan, 49085, United States

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Thiamine; Ascorbic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Eligible patients will be randomized in equal blinded proportions by the pharmacy department to receive thiamine, vitamin C and hydrocortisone in the experimental arm or continue with hydrocortisone plus placebo and usual standard of care treatment as discussed previously.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrollment for this study will be initiated in patients with septic shock that require addition of a second pressor agent. The control arm of our randomized trial will receive a second pressor agent, hydrocortisone and standard of care. If the patient needs additional pressor support or therapy, that will be recorded in the results. The experimental arm will receive a second pressor agent and hydrocortisone, plus thiamine and vitamin C along with the standard of care. If the patient needs additional pressor support or therapy that will be recorded in the results.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: May 30, 2018
• Study Start: February 26, 2018
• Primary Completion: February 26, 2020
• Study Completion: June 30, 2020
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)