Status:
TERMINATED
Evaluation of Hydrocortisone, Vitamin C and Thiamine for the Treatment of Septic Shock
Lead Sponsor:
Hamad Medical Corporation
Conditions:
Septic Shock
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 studi...
Detailed Description
Critically ill patients have low plasma levels of vitamin C. Additionally, ascorbic acid levels were inversely correlated with multi-organ dysfunction. Several studies have shown the benefit of using ...
Eligibility Criteria
Inclusion
- 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
- 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)
- 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.
- Patients with septic shock and requiring immediate surgery will be evaluated after surgery for inclusion.
Key Trial Info
Start Date :
March 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT03380507
Start Date
March 17 2018
End Date
November 1 2021
Last Update
December 10 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hamad Medical Corporation
Doha, Qatar, 3050