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

Last updated: November 3, 2022
Sponsor: Ain Shams University
Overall Status: Completed

Phase

4

Condition

Soft Tissue Infections

Treatment

N/A

Clinical Study ID

NCT05244018
FMASU MS 47/ 2022
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with sepsis and required mechanical ventilation (MV) within 24 hours fromICU admission.
  • Expected to require mechanical ventilation for at least 72 hours after study entry.

Exclusion

Exclusion Criteria:

  • Age <18 years.
  • inability to obtain informed consent from the patient and/or legally authorizedrepresentative.
  • 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.

Study Design

Total Participants: 80
Study Start date:
March 01, 2022
Estimated Completion Date:
October 31, 2022

Connect with a study center

  • Ain-Shams University Hospitals

    Cairo,
    Egypt

    Site Not Available

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