Vitamin D and Critically Ill Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Longxiang Su, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01636232
First received: July 5, 2012
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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.


Condition
Systemic Inflammatory Response Syndrome
Sepsis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • Patients Outcome [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.

  • Patients Outcome [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 234
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICU sepsis group
The ICU sepsis group consisting of 105 critically-ill cases diagnosed with sepsis upon admission and sampled within the first 24h of their ICU stay.
ICU control group
the ICU control group including 51 critically-ill cases in whom sepsis was clinically excluded and from whom samples were taken upon admission.
healthy control group
the healthy control group composed of 50 healthy control outpatients. For the healthy control outpatients, possibilities of acute or past chronic diseases were excluded. Moreover, we made sure that the healthy control subjects had not been hospitalized or taken vitamin-based substitutive drugs in the last 12 months, and proved normal in physical checkups and lab examinations.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

All the subjects were selected from among inpatients who were hospitalized between October-December, 2011 in the Surgical ICU, Respiratory ICU, and Emergency ICU, Chinese PLA General Hospital.

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01636232

Locations
China
Chinese PLA General Hospital
Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Director: Lixin Xie, MD Department Of Respiratory Diseases, Chinese PLA General Hospital
  More Information

No publications provided by Chinese PLA General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Longxiang Su, Dr., Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01636232     History of Changes
Other Study ID Numbers: CPLAGH-2012026
Study First Received: July 5, 2012
Last Updated: July 9, 2012
Health Authority: China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:
Vitamin D
infection
disease severity
mortality
critically ill
sepsis

Additional relevant MeSH terms:
Critical Illness
Sepsis
Systemic Inflammatory Response Syndrome
Disease Attributes
Pathologic Processes
Infection
Inflammation
Shock
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 21, 2014