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The Prognostic Value of Lactate is Different Among Septic Patients

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ClinicalTrials.gov Identifier: NCT04155060
Recruitment Status : Completed
First Posted : November 7, 2019
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief 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.

Condition or disease
Sepsis Diabetes Mellitus

Detailed 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.

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Study Type : Observational
Actual Enrollment : 256 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Prognostic Value of Lactate is Different Among Septic Patients With or Without Diabetes Mellitus
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
DM group , non-DM group
Septic patients were divided into the DM group and non-DM group, based on their comorbidity
high lactate group,low lactate group
high lactate group (lactate > 2 mmol/L) and low lactate group (lactate ≤ 2 mmol/L), according to the admission lactate level.



Primary Outcome Measures :
  1. The primary outcome was 28-day mortality [ Time Frame: up to at least 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Septic patients were recruited with lactate level obtained, and admission to the intensive care unit (ICU) .
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155060


Locations
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China, Shanghai
180 Fenglin Road
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Zhongshan Hospital
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04155060    
Other Study ID Numbers: PROMPT
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
hyperlactatemia
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases