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NCT04155060 Clinical Trial

The Prognostic Value of Lactate is Different Among Septic Patients

Diabetes Mellitus Clinical Trial

Official title:
The Prognostic Value of Lactate is Different Among Septic Patients With or Without Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04155060
Other study ID # PROMPT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date April 1, 2019

Study information
Verified date July 2020
Source Shanghai Zhongshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Early diagnosis of sepsis and identification of more severe sepsis is important to improve the outcomes .Therefore, reliable markers are required to early identify the high-risk patients. Currently, lactate is widely applied as the marker for evaluating the severity of sepsis and for outcome predicting. DM affects lactate balance and raised baseline lactate. The objective of this study was to compare the different prognostic value of admission lactate for sepsis patients with or without DM.

Description:

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Early diagnosis of sepsis and identification of more severe sepsis is important to improve the outcomes .Therefore, reliable markers are required to early identify the high-risk patients.

Currently, lactate is widely applied as the marker for evaluating the severity of sepsis and for outcome predicting.Nevertheless, the value of lactate for predicting sepsis is still controversial.The reasons for the different cutoff value may be due to the fact that sepsis is a heterogeneous disease which has already been defined by a number of clinical, laboratory and radiologic criteria, rather than specific pathologic findings. Therefore, we hypothesized that the discrepancy clinical value of lactate may be resulted from the heterogeneous feature of sepsis.

DM affects lactate balance and raised baseline lactate. The objective of this study was to compare the different prognostic value of admission lactate for sepsis patients with or without DM.

Recruitment information / eligibility
Status Completed
Enrollment 256
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:18 years or older, informed consent signed, admission serum lactate level obtained, and admission to the hospital with sepsis or septic shock diagnosis.

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Exclusion Criteria:congenital metabolic and psychiatric diseases and clinical data deficiency.

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Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China 180 Fenglin Road Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary outcome was 28-day mortality up to at least 28 days
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