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Active Not RecruitingNCT06711874

Abnormally High Parathyroid Hormone Levels Worsens Outcomes in Vitamin D Depleted Critical Care Patients

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
320 (estimated)
Sponsor
National Taiwan University Hospital · Academic / Other
Sex
All
Age
20 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2024-05-21
Primary completion
2024-12-31
Completion
2024-12-31
First posted
2024-12-02
Last updated
2024-12-02

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT06711874. Inclusion in this directory is not an endorsement.