Critically Ill Patients Admitted in ICU, Hyperparathyroidism, Vitamin D Deficiency
Conditions
Keywords
parathyroid hormone, vitamin D depletion, 25(OH)D, critical illness, mortality
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.
Interventions
None listed
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | From enrollment to day 90 | Survival on day 28, survival to hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Physiology and Chronic Health Evaluation II (APACHE II) score | From enrollment to day 90 | Apache II Score is a severity-of-disease classification system based on a number of laboratory values and patient signs taking both acute and chronic disease into account. An integer score from 0 to 71 with higher scores meaning a worse outcome. |
| Sequential Organ Failure Assessment (SOFA) score | From enrollment to day 90 | SOFA score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category. An integer score from 0 to 24 with higher scores meaning a worse outcome. |
| ICU length of stay | From enrollment to day 90 | The days patients stays in ICU |
| Laboratory parameters | From enrollment to day 90 | Serum levels of 25-hydroxyvitamin D (25(OH)D), calcium, parathyroid hormone (PTH), cortisol |
Countries
Taiwan