Health Condition 1: R652- Severe sepsis
Conditions
Interventions
Intervention1: Bolus ultra-high dose (540,000 IU of vitamin D3) vitamin D enterally: Adult ( more than and equal to 18 years old) medical patients admitted to the medical wards/ICUs with admission dia
repeat administration for another 8 weeks if 25-hydroxyvitamin D is still deficient. [vitamin D group (SD group)] The required number of vitamin D sachets would be were dissolved in sterile water an
Sponsors
Postgraduate Institute of Medical Education and Research Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than or equal to 18 years 2. Documented Vitamin Vitamin D levels less than 30 ng/ml 3. Increase in Sequential Organ Failure Assessment (SOFA) score of 2 along-with documented source of infection anywhere, either clinically or by laboratory/radiological investigation/s.
Exclusion criteria
Exclusion criteria: 1.Age less than 18 years 2.Pregnancy 3.Those who are taking calcium or Vitamin D supplementation 4.Known case of chronic renal failure, disorders of malabsorption, disorders of the thyroid 5.Those who are on drugs affecting Vitamin D levels such as antitubercular therapy, antiepileptics, ketoconazole (interference with hydroxylation in the liver) 6.Those who are on oral or parenteral steroids for more than 3 months (daily dose of 5 mg of prednisolone or its equivalents and a cumulative dose of more than 1 gram 7.Immobilization in the last 6 months 8.Those who are not giving written consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine reduction in hospital and 30 day mortality in patients with confirmed diagnosis of sepsis with deficient vitamin D levels at admission receiving large dose of vitamin D enteral supplementation as compared to low doseTimepoint: Hospital and 30 day mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are to ascertain the effectiveness of high dose enteral bolus of vitamin D supplementation on 1. Duration of mechanical ventilation 2. Requirement of renal replacement therapy 3. Requirement of vasoactive agents and duration of such need 4. Trends of biochemical and endocrine variables relevant to calcium- and phosphorus metabolism; 5. Trends of inflammatory markers like ESR, C-Reactive Protein and procalcitonin levels Timepoint: At admission, during hospital stay | — |
Countries
India
Contacts
Public ContactDivya C Ragate
Postgraduate Institute of Medical Education and Research
Outcome results
None listed