Vitamin C, Vitamin B1 and Steroid in Sepsis

NCT04039815 | Unknown Phase 4

• 1 other identifier: 107133-F
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled trial to test the synergic modulation effect of vitamin C, thiamine and hydrocortisone in patients with severe sepsis or septic shock.

Conditions

Sepsis, Severe

Outcome Measures

Primary Outcomes (1)

• The primary endpoint was the hospital survival.

  hospital survival

  30 days

Secondary Outcomes (23)

• duration of vasopressor therapy

  72 hours

• requirement for renal replacement therapy in patients with acute kidney injury (AKI)

  72 hours

• ICU length of stay (LOS)

  4 days

• change of Acute Physiology And Chronic Health Evaluation II (APACH II) score over the first 72 hours

  72 hours

• change of Acute Physiology And Chronic Health Evaluation II (APACH II) score over the first 72 hours

  72 hours

Study Arms (2)

ABC group (Ascorbic acid-Vitamin B1-Hydrocortisone) group

EXPERIMENTAL

patients in study group, so called" ABC" (Ascorbic acid-Vitamin B1-Hydrocortisone) group, would receive intravenous Thiamine (200mg in 50 mL of 0.9% normal saline and was administered as a 30-min infusion every 12 hours for 4 days or until ICU discharge), Vitamin C (1.5g mixed in a 100-mL solution of normal saline and was administered as an infusion over 30 to 60 min every 6 hours for four days or until ICU discharge) as well as hydrocortisone 50mg every 6 hours (or other equivalent products) for 7 days

Drug: Ascorbic acid-Vitamin B1-Hydrocortisone

normal saline group

PLACEBO COMPARATOR

patients would receive 50mL 0.9% normal saline, 100 mL 0.9% normal saline with the same infusion rate and hydrocortisone dependent on the discretion of the attending physician

Drug: Placebo

Interventions

Ascorbic acid-Vitamin B1-Hydrocortisone DRUG

intravenous Thiamine (200mg in 50 mL of 0.9% normal saline and was administered as a 30-min infusion every 12 hours for 4 days or until ICU discharge), plus Vitamin C (1.5g mixed in a 100-mL solution of normal saline and was administered as an infusion over 30 to 60 min every 6 hours for four days or until ICU discharge) as well as hydrocortisone 50mg every 6 hours (or other equivalent products) for 7 days

ABC group (Ascorbic acid-Vitamin B1-Hydrocortisone) group

Placebo DRUG

patients would receive 50mL 0.9% normal saline, 100 mL 0.9% normal saline with the same infusion rate and hydrocortisone dependent on the discretion of the attending physician

normal saline group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged equal or over 20
• admitted to MICU due to severe sepsis or septic shock

You may not qualify if:

• Patients who are pregnant
• known history of Vitamin C , Vitamin B or hydrocortisone (or other equivalent products) allergy

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

Taipei County, 100, Taiwan

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: as above
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double blind, randomized-controlled trial

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: July 31, 2019
• Study Start: December 3, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 6, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)