The Prognostic Value of Lactate is Different Among Septic Patients

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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 256

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • 180 Fenglin Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Septic patients were recruited with lactate level obtained, and admission to the intensive care unit (ICU) .

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome was 28-day mortality	up to at least 28 days

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: hyperlactatemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: PROMPT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No