Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preoperative Pulmonary Systolic Pressure and Outcome After Non-cardiac Surgery:Threshold Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03974919
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Yan Zhou, MD, Peking University First Hospital

Brief Summary:
The linear or nonlinear relationship of pulmonary systolic pressure and cardiovascular and kidney outcome after non-cardiac surgery is unknown. This study is to explore the relationship of the two and try to identify the possible threshold of pulmonary systolic pressure for major cardio-vascular events after non-cardiac surgery.

Condition or disease Intervention/treatment
Pulmonary Hypertension Other: NO intervention required

Detailed Description:

The linear or nonlinear relationship of pulmonary systolic pressure and cardiovascular and kidney outcome after non-cardiac surgery is unknown. This study is to explore the relationship of the two and try to identify the possible threshold of pulmonary systolic pressure for major cardio-vascular events after non-cardiac surgery.

Patients with preoperative cardio-echogram under going non-cardiac surgery were collected. The postoperative major cardiovascular, cerebral and kidney events were also identified and collected. Other data including peri-operative information and surgeries and anesthesia data were gathered.

Logistic regression models were built and selected. Independent risk factors relative to postoperative major cardiovascular and cerebral events were screened and identified. Odds ratio, relative risk and relative risk ratio of varies dichomitus cut points were calculated, trend breakpoint were identified, propensity score analysis were also done for causal inference.


Layout table for study information
Study Type : Observational
Actual Enrollment : 19000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Preoperative Pulmonary Systolic Pressure and Outcome After Non-Cardiac Surgery:Threshold Analysis
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : June 10, 2019
Actual Study Completion Date : June 11, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: NO intervention required
    NO intervention required


Primary Outcome Measures :
  1. major adverse events [ Time Frame: 30 days postoperatively in hospital ]
    cardiac infarction, heart failure, cardiac death, stroke, acute kidney injury



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
non-cardiac surgery adult patients with preoperative echocardiography
Criteria

Inclusion Criteria:

non-cardiac surgery patients with preoperative echocardiography records

Exclusion Criteria:

electronic records missing or peri-operative data missing


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974919


Locations
Layout table for location information
China, Beijing
First hospital Peking University
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital

Layout table for additonal information
Responsible Party: Yan Zhou, MD, Principal Investigator, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03974919     History of Changes
Other Study ID Numbers: MAEPSP
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yan Zhou, MD, Peking University First Hospital:
Pulmonary Hypertension, major cardiovascular event, non-cardiac surgery,threshold

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases