Calcitriol in Sepsis-A Single-Centre Randomised Control Trial

Area of Science:

• Critical Care Medicine
• Endocrinology
• Infectious Diseases

Background:

• Sepsis is a life-threatening organ dysfunction with high mortality, often requiring ICU admission.
• Vitamin D, specifically calcitriol, has potential immunomodulatory effects relevant to sepsis.
• Previous calcitriol studies in sepsis yielded variable results, lacking APACHE II score analysis.

Purpose of the Study:

• To evaluate the efficacy of intramuscular calcitriol in improving APACHE II scores in ICU patients with sepsis.
• To assess calcitriol's impact on secondary outcomes including mortality, ventilation, vasopressor use, and infection rates.

Main Methods:

• A triple-blinded, phase III randomized controlled trial involving 152 sepsis patients.
• Patients were randomized to receive either intramuscular calcitriol (300,000 IU) or a placebo.
• Primary endpoint was change in APACHE II scores from day 1 to day 7 or ICU discharge.

Main Results:

• No significant difference in APACHE II scores was observed between calcitriol and placebo groups.
• There were no statistically significant improvements in 28-day mortality, ventilator days, vasopressor days, or ICU length of stay.
• Rates of adverse events and hospital-acquired infections were also comparable between the groups.

Conclusions:

• Intramuscular calcitriol demonstrated no significant benefit for patients admitted to the ICU with sepsis.
• The study did not support the use of calcitriol for improving clinical outcomes in this patient population.