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Multiple Biomarkers in ICU Sepsis Patients

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ClinicalTrials.gov Identifier: NCT03802136
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
ZhiYong Peng, Zhongnan Hospital

Brief Summary:
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.

Condition or disease
Sepsis, Severe Sepsis Septic Shock AKI

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

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of Early Oxidative Stress Biomarkers in Patients With Sepsis
Actual Study Start Date : December 30, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

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



Primary Outcome Measures :
  1. 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

  2. Death of the patients [ Time Frame: 2 weeks after admission to ICU ]
    Mortality of the studied patients


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
serum and centrifuged urine will be retained in a -80℃ fridge


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients admitted to ICU of Zhongnan Hospital
Criteria

Inclusion Criteria:

  • sepsis patients in appropriate age

Exclusion Criteria:

  • ever blood transfusion ever CPR(cardiopulmonary resuscitation)

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): NCT03802136


Contacts
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Contact: zhiyong peng, professor 008618672396028 pengzy5@hotmail.com
Contact: Li He 008617798258617 helisoul@163.com

Locations
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China, Hubei
Zhongnan Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430000
Contact: zhiyong peng, professor         
Sponsors and Collaborators
Zhongnan Hospital
Investigators
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Study Director: zhiyong peng, professor Zhongnan Hospital
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Responsible Party: ZhiYong Peng, professor, Zhongnan Hospital
ClinicalTrials.gov Identifier: NCT03802136    
Other Study ID Numbers: 2018062
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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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 ZhiYong Peng, Zhongnan Hospital:
AKI
Sepsis
Biomarker
renal function
oxidative stress
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes