Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock

NCT03258684 | Completed

• 1 other identifier: Liao Yuping
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective clinical study, the investigators compare the outcome and clinical course of consecutive septic participants treated with intravenous vitamin C, hydrocortisone, and thiamine (treatment group) with a control group treated in the investigators' ICU. The primary outcome is hospital survival. A propensity score is generated to adjust the primary outcome.There is 70 participants in each group.

Conditions

Sepsis

Keywords

corticosteroid; hydrocortisone; septic shock; thiamine; vitamin C

Outcome Measures

Primary Outcomes (1)

• hospital survival

  Up to Day 14

Secondary Outcomes (5)

• duration of vasopressor therapy

  Up to hour 72

• requirement for renal replacement therapy in participants with Acute kidney injury(AKI)

  Up to Day 14

• ICU length of stay(LOS)

  Up to Day 14

• the change in serum procalcitonin (PCT)

  Up to hour 72

• Sepsis-Related Organ Failure Assessment(SOFA)score

  Up to hour 96

Study Arms (2)

vitamin C、hydrocortisone、thiamine

ACTIVE COMPARATOR

Intravenous vitamin C (1.5 g every 6 h for 4 days or until ICU discharge), hydrocortisone (50 mg every 6 h for 7 days or until ICU discharge followed by a taper over 3 days), as well as intravenous thiamine (200 mg every 12 h for 4 days or until ICU discharge).

Drug: Hydrocortisone, Vitamin C, and Thiamine

normal saline

PLACEBO COMPARATOR

Normal saline 500ml every day for 4 days，then 200ml every day for 3 days.

Other: Normal saline

Interventions

Hydrocortisone, Vitamin C, and Thiamine DRUG

Intervention

vitamin C、hydrocortisone、thiamine

Normal saline OTHER

Placebo

normal saline

Eligibility Criteria

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

You may qualify if:

• A primary diagnosis of sepsis or septic shock (the diagnoses of sepsis and septic shock are based on the 2016 the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)) and a procalcitonin (PCT) level≥2ng/mL.
• Sepsis: Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.
• Septic shock: Septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality.

You may not qualify if:

• Patients \< 18 years of age, pregnant patients, and patients with limitations of care.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University

Guangzhou, Guangdong, 510282, China

Location

Related Publications (2)

• Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J. Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study. Chest. 2017 Jun;151(6):1229-1238. doi: 10.1016/j.chest.2016.11.036. Epub 2016 Dec 6.

  PMID: 27940189 BACKGROUND

• Chang P, Liao Y, Guan J, Guo Y, Zhao M, Hu J, Zhou J, Wang H, Cen Z, Tang Y, Liu Z. Combined Treatment With Hydrocortisone, Vitamin C, and Thiamine for Sepsis and Septic Shock: A Randomized Controlled Trial. Chest. 2020 Jul;158(1):174-182. doi: 10.1016/j.chest.2020.02.065. Epub 2020 Mar 31.

  PMID: 32243943 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Hydrocortisone; Ascorbic Acid; Thiamine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants in treatment group receive intravenous vitamin C, hydrocortisone, and thiamine. The participants in control group receive normal saline.

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 23, 2017
• Study Start: September 25, 2017
• Primary Completion: February 2, 2019
• Study Completion: February 2, 2019
• Last Updated: March 12, 2019

Record last verified: 2019-01

Locations

CN (1)