Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation

• Status: Not yet recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

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 an additional 30% of patients being vitamin D insufficient, (25(OH)D = 20-30 ng/mL).Approximately 80% of sepsis/septic shock patients experience respiratory failure and require mechanical ventilation. Furthermore, several studies document that vitamin D deficiency could be associated with poor outcomes in critically ill patient.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.