Status:
NOT_YET_RECRUITING
The Impact of Selective Vitamin D Receptor Activation on Clinical Outcomes in Septic Patients
Lead Sponsor:
University of Split, School of Medicine
Conditions:
Sepsis
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Sufficient serum levels of vitamin D are important for immune system regulation with protective effect against severe infection and overactivated inflammatory response in sepsis. It is also not clear ...
Detailed Description
There are evidences that decreased vitamin D levels among septic patients shown significant associations with adverse outcomes. The large PETAL-VIOLET trial was conducted in 44 hospitals in the Unite...
Eligibility Criteria
Inclusion
- The participants of this study will be patients:
- admitted as sepsis in a medical ICU. The including criteria for sepsis will be defined according The Third International Consensus Definitions for Sepsis and Septic Shock. The sepsis will be defined as suspected infection with SOFA score\>=2.
- The subgroup of participants with septic shock will be defined as sepsis with vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L despite adequate fluid resuscitation.
Exclusion
- total serum calcium ≥2.60 mmol/L,
- significant chronic end stage heart, kidney or liver disease
- active treatment with corticosteroids or cytotoxic drugs
- autoimmune diseases
- malignancies
- cachexia
- previously been on active vitamin D therapy the last four months prior to the study period.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06209268
Start Date
May 1 2025
End Date
February 1 2026
Last Update
December 6 2024
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