NCT03227107

Brief Summary

  1. 1.enrollment criteria and clinical data collection: follow the principles of medical ethics, the development of inclusion and exclusion criteria, select 90 cases of ARDS patients, in the active treatment at the same time, according to the Berlin standard severity of the disease divided into mild group, moderate Group and severe group, according to the prognosis during hospitalization is divided into survival group and death group. BALF specimens were collected on the day of admission to detect the levels of NETs and alveolar macrophages. The acute and chronic health status scoring system Ⅱ (APACHEⅡ) and Murray acute lung injury score, blood routine, creatinine, urea nitrogen, fasting blood glucose, Item, mean arterial pressure, arterial blood gas analysis, oxygenation index; record the patient's mechanical ventilation time and other data;
  2. 2.Pearson linear correlation analysis of BALF in the content of NETs, alveolar macrophage coke death level was a positive correlation between the Spearman rank correlation analysis BALF in the NETs content and alveolar macrophage coke death level, APACHE Ⅱ, Murray score, creatinine, Urea nitrogen, fasting blood glucose and other indicators and ARDS severity was positively correlated;
  3. 3.To analyze the prognostic factors of different prognostic factors, to evaluate the content of NETs in BALF, the level of alveolar macrophage coke, APACHEⅡ and Murray scores were analyzed by receiver operator characteristic curve (ROC curve) Short - term survival outcome prognostic value.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 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

January 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

July 24, 2017

Status Verified

July 1, 2017

Enrollment Period

5 years

First QC Date

July 17, 2017

Last Update Submit

July 21, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • neutrophil extracellular traps, caspase-1,cytokines measurement

    Assessments with neutrophil extracellular traps be presented in ng/ml; Assessments with caspase-1 and cytokines be presented in pg/ml

    4 years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with ARDS

You may qualify if:

  • ARDS patients diagnosis within 3 days
  • Over 18 years old but no more than 75 years old

You may not qualify if:

  • Severe thoracic open trauma
  • Pulmonary embolism
  • Severe cardiovascular and cerebrovascular disease
  • Endocrine system diseases
  • Coagulation dysfunction
  • Liver and kidney failure
  • Malignant tumors
  • Cardiogenic pulmonary edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

Central Study Contacts

Li Haitao, Doctor

CONTACT

Pan Pinhua, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice director of department of respiratory

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 24, 2017

Study Start

January 1, 2016

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

July 24, 2017

Record last verified: 2017-07

Locations