NCT03802136

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

January 2, 2019

Last Update Submit

January 11, 2019

Conditions

Keywords

AKISepsisBiomarkerrenal functionoxidative stress

Outcome Measures

Primary Outcomes (2)

  • presence of AKI

    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

    Mortality of the studied patients

    2 weeks after admission to ICU

Secondary Outcomes (1)

  • Use serum creatinine to assess renal function of the patients

    the 1 day when the patients admitted to ICU

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients admitted to ICU of Zhongnan Hospital

You may qualify if:

  • sepsis patients in appropriate age

You may not qualify if:

  • ever blood transfusion ever CPR(cardiopulmonary resuscitation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and centrifuged urine will be retained in a -80℃ fridge

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • zhiyong peng, professor

    Zhongnan Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 14, 2019

Study Start

December 30, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

January 14, 2019

Record last verified: 2019-01

Locations