Health Condition 1: A418- Other specified sepsis
Conditions
Interventions
Intervention1: Calcitriol 300,000 IU Intramuscularly as a single dose (1 mL): Calcitriol 300,000 IU Intramuscularly as a single dose (1 mL)
Control Intervention1: Water for Injection 1 mL as Placebo:
Sponsors
Dr Siddhant J Thampi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged > 18 with suspected Sepsis 2. Sepsis will be defined by the following : Presence of SIRS presumed or confirmed to be due to an infectious etiology AND 3. qSOFA more than or equal to 2.
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Brain injury after cardiopulmonary arrest prior to recruitment 3. Patients who are severely ill with APACHE II > 40 (85% Mortality) and unlikely to survive for more than 24 hours 4. Current hypercalcemia > 10.8 mg/dL 5. History of therapy with high-dose vitamin D3 in the past 6 months 6. Patients with Platelets 1.3 7. CKD Patients who have received any form of Vitamin-D Supplementation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| APACHE II Scores will be determined in both arms at Day 0 at baseline and at Day 7 or discharge from ICU, whichever is shorter.Timepoint: APACHE II Scores will be determined in both arms at Day 0 at baseline and at Day 7 or discharge from ICU, whichever is shorter. | — |
Secondary
| Measure | Time frame |
|---|---|
| 28 day MortalityTimepoint: Day 0 to Day 28;Length of Hospital StayTimepoint: Day 0 to Discharge from Hospital;Length of ICU StayTimepoint: Day 0 to Discharge from ICU;Mean qSOFA scoreTimepoint: Day 0 to Day 7;New onset hospital acquired infection Timepoint: Day 0 to Day 7 of ICU Stay;Number of Inotrope DaysTimepoint: From day of initiation of Inotropes to day of halt of inotropes;Number of Ventilator DaysTimepoint: Day 0 to Day of Extubation;Rapid Shallow Breathing Index TrendTimepoint: Day 1 of Intubation until Day of extubation | — |
Countries
India
Contacts
Public ContactSiddhant J Thampi
Pondicherry Institute of Medical Sciences
Outcome results
None listed