Clinical Deterioration Caused by Elevated Parathyroid Hormone Levels Among Critically-Ill Patients With Vitamin D Depletion: a Secondary Analysis of a Multicenter, Prospective, Observational Study
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Mortality
Overview
Brief Summary
This study aims to investigate the impacts of abnormally elevated PTH levels on clinical outcomes among critically ill patients with vitamin D depletion.
Detailed Description
This study is a secondary analysis of data from a previous multicentre, prospective, observational cohort study (REC No: 201805087RINB) examining vitamin D deficiency prevalence and outcomes in critical care. From the previously enrolled 651 critically ill patients admitted to medical and surgical intensive care units (ICUs), those enrolled within 48 hours of admission are analyzed. Vitamin D depletion is defined as a serum 25-hydroxyvitamin D (25(OH)D) level <30 ng/mL. Patients are categorized as PTH non-responders (PTH levels of 15-68.3 pg/mL) or PTH responders (PTH levels > 68.3 pg/mL). The primary endpoints include the rate of survival to day 28 and the rate of survival to hospital discharge. Secondary endpoints include the length of ICU stay at day 28 and day 90, Acute Physiology and Chronic Health Evaluation (APACHE) II score, Sequential Organ Failure Assessment (SOFA) score, and blood clinical laboratory variables.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mortality
Time Frame: From enrollment to day 90
Survival on day 28, survival to hospital discharge
Secondary Outcomes
- Acute Physiology and Chronic Health Evaluation II (APACHE II) score(From enrollment to day 90)
- Sequential Organ Failure Assessment (SOFA) score(From enrollment to day 90)
- ICU length of stay(From enrollment to day 90)
- Laboratory parameters(From enrollment to day 90)