Objectives: The effect of vitamin D 3 supplementation on clinical outcomes and prognostic biological indicators (eg, CRP, interleukin-6 and Procalcitonin) in mechanically ventilated patients with pneumonia that suffered from deficiency of vitamin D3.
Design: This study will be done as a randomized clinical trial on 46 patients suffering from ventilator associated pneumonia admitted to the intensive care unit of Loghman Hakim and Shohadaye Tajrish hospitals.
Setting and conduct: Patients during the first 48 hours after the diagnosis of pneumonia caused by mechanical ventilation were enrolled and randomly divided into 2 groups. One group of patients will receive 300,000 IU of vitamin D3 as intramuscular injection and the other group will receive placebo. On the first day of study level of 25-hydroxy vitamin D3, CRP, IL-6, Procalcitonin and parameters included age, sex, underlying disease, medications, SOFA score and CPIS score, liver function and renal failure, clinical findings of pneumonia, CBC, body temperature, vital signs and location will be examined and recorded. Following the treatment, the daily CBC, body temperature and respiratory secretions been assessed and recorded. On the seventh day of treatment, the level of 25-hydroxyvitamin D3, CRP, IL-6, Procalcitonin, CPIS score and SOFA score were measured, and during this period the patient’s treatment will modify according to the results of cultures of lung secretions and clinical changes. Finally in the 28th day of study evaluation of 28 day mortality will be performed for all patients.
Participants including major eligibility criteria: Patients over 18 years old, that clinically and based on the following criteria have been diagnosed with VAP (During the first 48 hours of diagnosis): The presence of new or progressive infiltration on the patient's chest radiograph that occur 48-72 hours after initiation of mechanical ventilation, While two of the following symptoms must be present with it: Fever over 38 ° C; leukocytosis or leukopenia (white blood cell count greater than 12,000 per µL of blood or less than 4000 per µL of blood) and purulent pulmonary secretions. The exclusion criteria included: Stage3 or more chronic kidney problems; liver problems with CHILD-PUGH stage B or C; history of cancer within the last 3 months, or currently taking chemotherapy drugs; patients with immune deficiency; pancreatitis; other infections, concurrently with pneumonia caused by mechanical ventilation, patients with VAP that the vitamin D levels are normal and Coagulopathy.
Intervention: One group of patients will receive 300,000 IU of vitamin D3 as intramuscular injection and the other group will receive placebo.
Main outcome measures: Level of 25-hydroxy vitamin D3, CRP, IL-6, Procalcitonin, SOFA score and CPIS score and outcome of the 28-day.