Vitamin D and Critically Ill Patients

Sepsis Clinical Trial

Official title:

Vitamin D Levels and Risk of Infection, Assessment for Disease Severity, and Predictor of Mortality in the Chinese Intensive Care Units: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636232
• Other study ID #: CPLAGH-2012026
• Status: Completed
• Phase: N/A
• First received: July 5, 2012
• Last updated: June 3, 2016
• Start date: October 2011
• Est. completion date: December 2011

Study information

• Verified date: June 2016
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The higher rate of vitamin D deficiency is spotted among patients being hospitalized or in critical condition. Especially, vitamin D level below normal prolongs hospital stay and increases incidence of adverse prognosis and pushing up mortality of a number of diseases. However, it is remain unclear the relationship between vitamin D levels and critically ill, especially infection or sepsis. In this study, the investigators evaluate the significance of vitamin D for diagnosis and other relevant assessments of ICU cases, including vitamin D's relevance to sepsis, as well as its value in severity and prognosis assessment, high-performance liquid chromatography and tandem mass spectrometry was used to detect the quantification of the total 25(OH)D in serum of critically ill patients. The investigators speculate that measurement of vitamin D could be taken as an indicator for diagnosis and assessment in critically ill patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female aged 18 years old and over;

• Entered ICU;

• Fulfilled at least two criteria of systemic inflammatory response syndrome

• core temperature higher than 38 °C or lower than 36 °C

• respiratory rate above 20/min, or PCO2 below 32 mmHg

• pulse rate above 90/min, and

• white blood cell count greater than 12,000/µl or lower than < 4,000/µl or less than 10% of bands.

Exclusion Criteria:

• patients or their relatives refused

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Systemic Inflammatory Response Syndrome

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Outcome	The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death.	28 days	No
Primary	Patients Outcome	The survival time of patients more than 90 days is defined as survival. The survival time of patients less than 90 days is defined as death.	90 days	No