NCT02920736

Brief Summary

The purpose of this study is to determine the value of urine sTREM-1 on early predicting secondary acute kidney injury in sepsis

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

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

January 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

September 29, 2016

Last Update Submit

September 29, 2016

Conditions

Acute Kidney InjurySepsis

Outcome Measures

Primary Outcomes (1)

  • urine soluble triggering receptor expressed on myeloid cells-1

    3 years

Study Arms (3)

sepsis with acute renal injury group

Based on definition of sepsis with Sepsis 3.0 and AKI was defined using KDIGO（Kidney Disease: Improving Global Outcomes） consensus definition of AKI.The group was the secondary AKI in sepsis patients

sepsis non-acute renal injury group

The group was the non-AKI in sepsis patients

control group

Approximately 110 persons(18-80years) with healthy physical examination and without liver and kidney dysfunction

Eligibility Criteria

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

All subjects were selected from among inpatients who were hospitalized between Sep.2016 and Dec.2018 in the Respiratory ICU, Surgical ICU and Emergency ICU of 6 general hospitals in Beijing.All subjects were diagnosed with sepsis, based on the Sepsis 3.0.

You may qualify if:

  • All subjects meet the standards of sepsis 3.0 diagnostic criteria for the diagnosis of sepsis.

You may not qualify if:

  • The following situations can not occur when all subjects are enrolled
  • Age\> 80 years or \<18 years
  • Chronic renal insufficiency, renal transplantation
  • Blood purification treatment
  • AKI has occurred

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

    PMID: 26903338BACKGROUND

  • Ad-hoc working group of ERBP; Fliser D, Laville M, Covic A, Fouque D, Vanholder R, Juillard L, Van Biesen W. A European Renal Best Practice (ERBP) position statement on the Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guidelines on acute kidney injury: part 1: definitions, conservative management and contrast-induced nephropathy. Nephrol Dial Transplant. 2012 Dec;27(12):4263-72. doi: 10.1093/ndt/gfs375. Epub 2012 Oct 8. No abstract available.

    PMID: 23045432BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and urine

MeSH Terms

Conditions

Acute Kidney InjurySepsis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • lixin xie, Ph.D.

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 29, 2016

First Posted

September 30, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 30, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share