Health Condition 1: B999- Unspecified infectious disease
Conditions
Interventions
Intervention1: cholecalciferol: single dosage of cholecalciferol of 540,000 units in 45 ml of plain water administered on a single day .
Control Intervention1: placebo: 45 ml of plain water
Sponsors
Dr amrita bhattacharyya
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 to 80 years 2. Presenting to the emergency department and expected to be admitted to the ICU and survive for more than 96 hours. 3. Meet criteria for sepsis within past 12 hours 4. Enteral access in place to enable delivery of vitamin D or placebo and are deemed to be able to tolerate enteral drug administration
Exclusion criteria
Exclusion criteria: 1. History of malabsorption syndromes or currently having gastrointestinal intolerance in the form of diarrhoea, vomiting or increased naso gastric aspirates. 2. Other trial participation, 3. Pregnant or lactating women; 4. Patients not deemed suitable for study participation (i.e., psychiatric disease, living remotely from the clinic, or prisoner status). 5. Age =80 years 6. Inability to obtain informed consent from patient/suitable proxy within 22 hours of new-onset severe sepsis 7. Comfort measures, hospice, or palliative care status 8. Documented adverse reaction to vitamin D supplementation Renal stones within past year Hypercalcemia within past year Baseline serum calcium >=10.5 mg/dL Established diagnosis of medical condition associated with high risk of hypercalcemia (e.g. metastatic cancer, sarcoidosis, multiple myeloma, primary hyperparathyroidism current hypercalcemia (albumin-corrected serum calcium > 10.8 mg/dL or ionized calcium > 5.2 mg/dL) 9. History of therapy with high dose vitamin D3 (greater than or equal to 50,000 IU a week) to treat vitamin D deficiency, within previous 6 months 10. Chronic dialysis; 11. >24 hours of sepsis diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the ICU length of stay between the two groups administered vitamin D and placeboTimepoint: Vitamin D administered post randomization , ICU length of stay asessed at the end of ICU stay. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare between the drug and placebo groups: 1. 90-day mortality 2. hospital length of stay, 3. mean duration of mechanical ventilation, 4. mean duration of vasopressor requirement 5. change is procalcitonin level from baseline to Day 5 6. change is SOFA score from baseline to Day 5 7. To estimate prevalence of vitamin D deficiency in ICU patients with sepsis and correlate it with sepsis severity as defined by the SOFA score Timepoint: at day 7 | — |
Countries
India
Contacts
Public Contactdr amrita bhattacharyya
AIIMS , New Delhi
Outcome results
None listed