Status:
COMPLETED
Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation
Lead Sponsor:
Ain Shams University
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
There is a high prevalence of vitamin D deficiency in the critically ill patient population, with approximately 60% of patients found to be vitamin D deficient, (25(OH)D concentrations \<20 ng/mL) and...
Eligibility Criteria
Inclusion
- Diagnosed with sepsis and required mechanical ventilation (MV) within 24 hours from ICU admission.
- Expected to require mechanical ventilation for at least 72 hours after study entry.
Exclusion
- Age \<18 years.
- inability to obtain informed consent from the patient and/or legally authorized representative.
- BMI\> 40.
- Pregnant or breastfeeding.
- Chronic kidney diseases
- Pancreatitis.
- Hepatic insufficiency
- Cases with coagulopathy
- Moribund and not expected to survive 96 hours.
- Ongoing shock
- History of therapy with high dose vitamin D3 within previous 6 months.
- History of disorders associated with hypercalcemia
- Cancer as the cause of sepsis.
- Subjects undergoing chemotherapy.
- Immune compromised patients.
- Pneumonia developed \< 48 hours following intubation.
- Patients with history of aspiration before intubation.
- known allergy to vitamin D.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05244018
Start Date
March 1 2022
End Date
October 31 2022
Last Update
November 7 2022
Active Locations (1)
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1
Ain-Shams University Hospitals
Cairo, Egypt