Multiple Biomarkers in ICU Sepsis Patients

• Sponsor: Zhongnan Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03802136
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 23.9

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Design

• Study Type: Observational
• Anticipated 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: Dec 30, 2018
• Anticipated Primary Completion Date: Jun 1, 2019
• Anticipated Study Completion Date: Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. presence of AKI [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 [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 [the 1 day when the patients admitted to ICU]

   Concetration of serum creatinine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• sepsis patients in appropriate age

Exclusion Criteria:

• ever blood transfusion ever CPR（cardiopulmonary resuscitation)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongnan Hospital of Wuhan University	Wuhan	Hubei	China	430000

Sponsors and Collaborators

• Zhongnan Hospital

Investigators

• Study Director: zhiyong peng, professor, Zhongnan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ZhiYong Peng, professor, Zhongnan Hospital
• ClinicalTrials.gov Identifier: NCT03802136
• Other Study ID Numbers: 2018062
• First Posted: Jan 14, 2019
• Last Update Posted: Jan 14, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ZhiYong Peng, professor, Zhongnan Hospital: AKI; Sepsis; Biomarker; renal function; oxidative stress
• Additional relevant MeSH terms: Sepsis; Toxemia

Study Results

No Results Posted as of Jan 14, 2019