Vitamin D and Critically Ill Patients

NCT ID: NCT01636232

Last Updated: 2016-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Inflammatory Response Syndrome Sepsis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Longxiang Su

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lixin Xie, MD

Role: STUDY_DIRECTOR

Department Of Respiratory Diseases, Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, , China

Site Status

Countries

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China

References

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Su LX, Jiang ZX, Cao LC, Xiao K, Song JP, Li H, Zhang X, Yan P, Feng D, Liu CT, Li X, Xie LX. Significance of low serum vitamin D for infection risk, disease severity and mortality in critically ill patients. Chin Med J (Engl). 2013 Jul;126(14):2725-30.

Reference Type DERIVED
PMID: 23876904 (View on PubMed)

Other Identifiers

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CPLAGH-2012026

Identifier Type: -

Identifier Source: org_study_id

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