Risk Factors and Prediction Score of ARDS After Cardiac Surgery

January 28, 2021 updated by: Guangfa Zhu, Beijing Anzhen Hospital
Acute respiratory distress syndrome following cardiac surgery severely affects the prognosis of patients; the mortality is up to 40%. Although experience many years of research and exploration, the effective methods for the treatment of acute respiratory distress syndrome is still relatively limited at present, including lung protective mechanical ventilation respiratory support, fluid management, glucocorticoid and other integrated organ function maintenance measures. It is currently the research of acute respiratory distress syndrome aims at the early discovery and takes effective measures to prevent its occurrence, hoping to improve the prognosis of patients. According to risk factors is established through the analysis of lung injury score early warning system, the early identification of acute respiratory distress syndrome patients at high risk, before the occurrence of acute respiratory distress syndrome take corresponding preventive measures can effectively reduce the incidence rate and mortality. So far, domestic and foreign research on the establishment of acute respiratory distress syndrome scoring early warning system is less. Cardiac surgery has significant characteristics, type of operation, location, operation, intraoperative blood transfusion and oxygenation, postoperative factors, are likely to be the factors of acute respiratory distress syndrome. As far as investigators know, so far there are few specialized for acute respiratory distress syndrome predicting lung injury after cardiac surgery. This study will be completed after the implementation of individualized dynamic lung injury score evaluation of cardiac surgery patients, identification of high-risk acute respiratory distress syndrome patients, to assist clinicians in early decision, take preventive measures. This study will improve the prognosis of acute respiratory distress syndrome patients after cardiac surgery; it is of great significance to improve the level of intensive care after cardiac surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1333

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of cardiac surgery in Beijing Anzhen hospital

Description

Inclusion Criteria:

  • Retrospective group: cardiac surgery patients accepted from Jan 2013 to Dec 2015
  • Prospective group: cardiac surgery patients accepted from 2017 January to December

Exclusion Criteria:

  • refused to participate in the study
  • age less than 18 years old
  • before operation performed mechanical ventilation
  • before operation underwent IABP treatment
  • before operation continuous renal replacement therapy
  • before operation undergoing in vitro membrane oxygenator treatment
  • before operation has the pulmonary imaging showed bilateral pulmonary diffuse exudation of interstitial pneumonia, pulmonary infection or respiratory failure
  • the major trauma, sepsis, aspiration, shock, acute heart failure
  • before operation diagnosed as malignant tumor
  • Incomplete data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ARDS
ARDS patients after cardiac surgery
Other: no intervention
This is a clinical observational study, no intervention was included.
non-ARDS
non-ARDS patients after cardiac surgery
Other: no intervention
This is a clinical observational study, no intervention was included.
propective group
patients of cardiac surgery including ARDS and non-ARDS patients
Other: no intervention
This is a clinical observational study, no intervention was included.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Time Frame: up to 12months
up to 12months
The number of patients of cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Time Frame: up to 12months
up to 12months
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
Time Frame: up to 12months
up to 12months
The number of patients of cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
Time Frame: up to 12months
up to 12months
The number of diabetic patients in ARDS group.
Time Frame: up to 1 month
up to 1 month
The number of diabetic patients in non-ARDS group.
Time Frame: up to 1 month
up to 1 month
The number of chronic obstructive pulmonary disease patients in ARDS group.
Time Frame: up to 1 month
up to 1 month
The number of chronic obstructive pulmonary disease patients in non-ARDS group.
Time Frame: up to 1 month
up to 1 month
The type of operation in ARDS group.
Time Frame: up to 1 month
up to 1 month
The type of operation in non-ARDS group.
Time Frame: up to 1 month
up to 1 month
The body mass index in ARDS group.
Time Frame: up to 1 month
up to 1 month
The body mass index in non-ARDS group.
Time Frame: up to 1 month
up to 1 month
The heart function in ARDS group before operation.
Time Frame: up to 1 month
up to 1 month
The heart function in non-ARDS group before operation.
Time Frame: up to 1 month
up to 1 month
The oxygenation in ARDS group before operation.
Time Frame: up to 1 month
up to 1 month
The oxygenation in non-ARDS group before operation.
Time Frame: up to 1 month
up to 1 month
The drug taken by patients in ARDS group.
Time Frame: up to 1 month
up to 1 month
The drug taken by patients in non-ARDS group.
Time Frame: up to 1 month
up to 1 month
The nutrition situation of patients in ARDS group.
Time Frame: up to 1 month
up to 1 month
The nutrition situation of patients in non-ARDS group.
Time Frame: up to 1 month
up to 1 month
The process of operation in ARDS group.
Time Frame: up to 1 month
up to 1 month
The process of operation in non-ARDS group.
Time Frame: up to 1 month
up to 1 month
The blood transfusion of patients during operation in ARDS group.
Time Frame: up to 1 month
up to 1 month
The blood transfusion of patients during operation in non-ARDS group.
Time Frame: up to 1 month
up to 1 month
The oxygenation of patients during operation in ARDS group.
Time Frame: up to 1 month
up to 1 month
The oxygenation of patients during operation in non-ARDS group.
Time Frame: up to 1 month
up to 1 month
The drug taken by patients after operation in ARDS group.
Time Frame: up to 1 month
up to 1 month
The drug taken by patients after operation in non-ARDS group.
Time Frame: up to 1 month
up to 1 month
The oxygenation of patients after operation in ARDS group.
Time Frame: up to 1 month
up to 1 month
The oxygenation of patients after operation in non-ARDS group.
Time Frame: up to 1 month
up to 1 month
The situation of mechanical ventilation of patients after operation in ARDS group.
Time Frame: up to 1 month
up to 1 month
The situation of mechanical ventilation of patients after operation in non-ARDS group.
Time Frame: up to 1 month
up to 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The mortality of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Time Frame: up to 1months
up to 1months
The morbidity of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Time Frame: up to 1months
up to 1months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Anzhen Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Guangfa Zhu, Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Shoufa-2016-2-1052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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