Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-25 @ 4:43 AM
NCT ID:
NCT05244018
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05244018
Study Brief:
Protocol Section:
NCT05244018