- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01636232
Vitamin D and Critically Ill Patients
June 3, 2016 updated by: Longxiang Su, Chinese PLA General Hospital
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
234
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100853
- Chinese PLA General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients Outcome
Time Frame: 28 days
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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.
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28 days
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Patients Outcome
Time Frame: 90 days
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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.
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90 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
July 5, 2012
First Submitted That Met QC Criteria
July 9, 2012
First Posted (Estimate)
July 10, 2012
Study Record Updates
Last Update Posted (Estimate)
June 6, 2016
Last Update Submitted That Met QC Criteria
June 3, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPLAGH-2012026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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