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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06711874
Enrollment
320
Registered
2024-12-02
Start date
2024-05-21
Completion date
2024-12-31
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill Patients Admitted in ICU, Hyperparathyroidism, Vitamin D Deficiency

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

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
MortalityFrom enrollment to day 90Survival on day 28, survival to hospital discharge

Secondary

MeasureTime frameDescription
Acute Physiology and Chronic Health Evaluation II (APACHE II) scoreFrom enrollment to day 90Apache 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) scoreFrom enrollment to day 90SOFA 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 stayFrom enrollment to day 90The days patients stays in ICU
Laboratory parametersFrom enrollment to day 90Serum levels of 25-hydroxyvitamin D (25(OH)D), calcium, parathyroid hormone (PTH), cortisol

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026