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

Ain Shams University

Status and phase

Completed

Phase 4

Conditions

Sepsis

Treatments

Drug: Vitamin D3 tablets

Drug: Vitamin D tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT05244018

FMASU MS 47/ 2022

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.