Health Condition 1: null- Sepsis Health Condition 2: A419- Sepsis, unspecified organism
Conditions
Interventions
Intervention1: Injection Vitamin C: Intravenous Vitamin C 1.5 g every 6 hours for 4 days (24 doses)
The drug will be purchased from Liv-Biopharma (Inj. Livocee). The solution will be reconstituted in
which will be packed in similar vials as the intervention agent.
The placebo will be prepared in the Pharmacy of Christian Medical College, Vellore and packaged in a sterile manner like that of the dr
Sponsors
Amith Balachandran
Eligibility
Inclusion criteria
Inclusion criteria: 1)Has completed the age of 18 years 2)Has the diagnosis of Sepsis. Sepsis if defined in accordance with the â??Sepsis 3â?? Criteria as â??as life threatening organ dysfunction due to a dysregulated host response to infectionâ??. Sepsis is hence identified if there is organ dysfunction and a suspected or proven infection. 2a-Organ dysfunction is defined as an increase in SOFA Score of 2 or more. If there is no known pre-existing organ dysfunction, the baseline SOFA Score will be assumed to be Zero. This is also in accordance with the â??Sepsis 3â?? Definition. 2b-Suspected infection is defined when all of the below 3 criteria are met •Clinical syndrome consistent with infection (fever, tachycardia, warm shock, hyperthermia/hypothermia, acute oliguria, tachypnea, altered mental status etc.) along with supporting laboratory (leukocytosis or leucopenia, immature WBCs >10%, hyperglycemia in the absence of diabetes, elevated CRP, arterial hypoxia, elevated creatinine, coagulation abnormalities, thrombocytopenia, hyperbilirubinemia, hyperlactatemia, elevated procalcitonin) or radiological data (infiltrates on Chest X Ray, collection on ultrasound etc.) and •The diagnosis of sepsis was made by the treating physician and •Blood culture(s) is drawn and non-empirical antibiotics initiated. 2c-Proven Infection is identified using standard diagnostic criteria described for various infectious syndromes like Primary blood stream infection, Catheter related blood stream infection, Community acquired pneumonia, Hospital acquired pneumonia, Ventilator associated pneumonia, Urinary tract infection, Catheter associated urinary tract infection, Meningitis, Intracranial infection, skin and soft tissue infections, Infective endocarditis and Spontaneous bacterial peritonitis .
Exclusion criteria
Exclusion criteria: 1) Pregnant and lactating Women 2) Patients who are enrolled to other interventional trials 3) Past or present of renal stones according to history, medical/laboratory records from elsewhere or hospital electronic medical records. Patients will not be screened for renal stones or oxaluria 4) Patients who are receiving Vitamin C for another indication (e.g.: Wound healing, Burn Injuries, along with Inj. Doxycycline).Patients who are enrolled to the trial will be allowed to be initiated on Doxycycline if indicated and will be included in the ITT analysis. Such patients will be specially mentioned while reporting the results. 5) Patients with known allergy to Vitamin C 6) Patients with known G-6-PD deficiency and Hemochromatosis 7) Patients with KDIGO 3 Acute Kidney Injury or Class 4 or 5 CKD 8) Patients who are receiving Warfarin or related drugs, Bortezomib or Cyclosporine 9) Patients who were once enrolled in the trial and has received at least one dose of the drug will be excluded if they are readmitted to ICU with a new onset Sepsis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In hospital all-cause mortalityTimepoint: Till Discharge or Death, whichever earlier | — |
Secondary
| Measure | Time frame |
|---|---|
| Days alive and free from Inotropes/VasopressorsTimepoint: Till Discharge or Death, whichever earlier;Days alive and free from VentilatorTimepoint: Till Discharge or Death, whichever earlier;Hospital Length of StayTimepoint: Not Applicable;ICU Length of StayTimepoint: Not Applicable;New onset organ dysfunctionTimepoint: Till Discharge or Death, whichever earlier;Time to vasopressor independence in participants who surviveTimepoint: Not Applicable;Days alive and free from DialysisTimepoint: Till Discharge or Death, whichever earlier | — |
Countries
India
Contacts
Public ContactAmith Balachandran
Christian Medical College & Hospital,Vellore
Outcome results
None listed