Multiple Biomarkers in ICU Sepsis Patients

January 11, 2019 updated by: ZhiYong Peng, Zhongnan Hospital

Prognostic Value of Early Oxidative Stress Biomarkers in Patients With Sepsis

Acute kidney injury (AKI) is a common condition among sepsis patients in the intensive care unit (ICU) and is associated with high morbidity and mortality. Oxidative stress biomarkers were investigated in panels and were reported to predict renal failure in sepsis patients. Some biomarkers would be able to identify who will recover and not recover better than serum creatinine. Thus, a combining oxidative stress biomarkers are needed to predict the occurrence or progression of AKI in critically ill patients.

Study Overview

Status

Unknown

Conditions

Detailed Description

Acute kidney injury (AKI) is a common condition among sepsis patients in the intensive care unit (ICU) and is associated with high morbidity and mortality. Oxidative stress biomarkers were investigated in panels and were reported to predict renal failure in sepsis patients. Research on AKI has focused on new damage biomarkers for early detection of AKI and worsening of renal function. Some biomarkers would be able to identify who will recover and not recover better than serum creatinine. Thus, a combining functional and damage markers as well as oxidative stress biomarkers are needed to predict the occurrence or progression of AKI in critically ill patients. Therefore, this prospective, observational study will be conducted in Mainland China

Study Type

Observational

Enrollment (Anticipated)

120

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

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
          • zhiyong peng, professor

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients admitted to ICU of Zhongnan Hospital

Description

Inclusion Criteria:

  • sepsis patients in appropriate age

Exclusion Criteria:

  • ever blood transfusion ever CPR（cardiopulmonary resuscitation)

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
high concentration of biomarkers
the patients with biomarkers level over the normal max value
low concentration of biomarkers
the patients with biomarkers level below the normal max value

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of AKI
Time Frame: a week after admission to ICU
Use serum creatinine or urine output（The KDIGO Guidelines 2012) to asess whether AKI happens to the studied subjects within a week after admission to ICU
a week after admission to ICU
Death of the patients
Time Frame: 2 weeks after admission to ICU
Mortality of the studied patients
2 weeks after admission to ICU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use serum creatinine to assess renal function of the patients
Time Frame: the 1 day when the patients admitted to ICU
Concetration of serum creatinine
the 1 day when the patients admitted to ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Investigators

  • Study Director: zhiyong peng, professor, Zhongnan Hospital

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 (Actual)

December 30, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

January 2, 2019

First Submitted That Met QC Criteria

January 11, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018062

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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