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

• Status: Unknown status
• Trial end date: 2019-05-30
• Target enrollment: 0
• Participant gender: All

Summary

Despite recent medical advances, sepsis and septic shock remain a major cause of death. Sepsis is a syndrome with a wide array of physiologic, pathologic, and biochemical abnormalities.

Several studies have shown vitamin C have decreased the circulating pro-inflammatory cytokines and oxidative stress.Thiamine had favorable effects on pro-inflammatory cytokines, oxidative stress and cellular hypoxia.The use of hydrocortisone in combination with vitamin C will increase the transport of vitamin C into the cells; since the pro inflammatory cytokines have shown to decrease the expression of the sodium-vitamin C transporter-2 (SVCT2) while glucocorticoids increase the SVCT2 expression.

A recent small retrospective study , showed a significant decrease in mortality when patients with severe sepsis and septic shock are treated with a combination of Hydrocortisone, Vitamin C, and Thiamine. Conducting a similar study with a prospective randomized design will give clinicians all over the world more answers and will help clinicians to provide better care to millions of patients using highly safe therapeutic regimen.

The objective of the current study is to explore the clinical benefits of using a combination of hydrocortisone, vitamin C, and thiamine (triple therapy) for the management of septic shock. To achieve this objective, we will compare two alternative treatment strategies, either triple therapy or usual care in patients with septic shock.

First aim: To assess the effectiveness of the triple therapy for septic shock

Second aim: To assess the safety of triple therapy

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Hydrocortisone; Thiamine

Criteria

Inclusion Criteria:

• Age (above 18 years old)

• Suspected or documented infection

• Meeting the definition of septic shock (Sepsis 3 definitions); Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressor therapy to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L despite adequate volume resuscitation.

• Receiving norepinephrine at a dose equal or more than 0.1 µg/kg/min for more than or equal 6 hours.

Exclusion Criteria:

• Known pregnancy(1)

• Primary diagnosis of acute cerebral vascular event

• Acute coronary syndrome

• Status asthmaticus

• Major cardiac arrhythmia

• Active gastrointestinal hemorrhage

• Seizure

• Drug overdose

• Burn or trauma

• Requirement for immediate surgery(2)

• Absolute neutrophil count <500 mm3

• CD4 <50/mm³

• Do-not-resuscitate status

• Advanced directives restricting implementation of the protocol

• Terminally ill patients in palliative care

• Participation in another interventional study

• Known allergy or contraindication to one or more of the trial medications (Vitamin C, Thiamine, or Hydrocortisone)

1. If the pregnancy status is unknown, the pregnancy test will not be done as part of the usual care, the patient is unconscious, and consent cannot be obtained for pregnancy test; we will not enroll the patient.

2. Patients with septic shock and requiring immediate surgery will be evaluated after surgery for inclusion.