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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01636232
Other study ID # CPLAGH-2012026
Secondary ID
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
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