Clinical trial NCT06711874: Abnormally High Parathyroid Hormone Levels Worsens Outcomes in Vitamin D Depleted Critical Care Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vitamin D Deficiency
Hyperparathyroidism
Critically Ill Patients Admitted in ICU
Keywords: parathyroid hormone
vitamin D depletion
25(OH)D
critical illness
mortality
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 320
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patient

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.

Eligibility criteria: Inclusion criteria:

1. Critically ill patients within 48 hours of ICU admission

Exclusion criteria:

1. Less than 20 years old
2. Severe malnutrition (BMI\<18kg/m2)
3. Severe anemia (hemoglobin concentration \<7g/dL)
4. Receiving high-dose vitamin D treatment (\> 3000 IU/day) within four weeks
5. Have been admitted to the ICU within three months
6. Suffering from diseases that affect vitamin D concentration, calcium metabolism or bone metabolism (for example: parathyroid disease, rickets, chirtosis, and severe cirrhosis \[Child C\])
7. Patients and family members who do not speak the native language

Primary outcomes:
measure: Mortality
timeFrame: From enrollment to day 90
Secondary outcomes:
measure: Acute Physiology and Chronic Health Evaluation II (APACHE II) score
timeFrame: From enrollment to day 90
measure: Sequential Organ Failure Assessment (SOFA) score
timeFrame: From enrollment to day 90
measure: ICU length of stay
timeFrame: From enrollment to day 90
measure: Laboratory parameters
timeFrame: From enrollment to day 90
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: