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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02475694
Other study ID # N-20080016
Secondary ID
Status Completed
Phase N/A
First received May 21, 2015
Last updated June 16, 2015
Start date September 2008
Est. completion date March 2009

Study information

Verified date June 2015
Source Aalborg Universitetshospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of the present study is to visualize the inflammatory response and coagulation disorders during cardiac surgery in order to identify possible predictors for acute lung injury postoperatively.


Description:

Acute lung injury after cardiac surgery is a common complication. The pathophysiology is complex and still not fully elucidate. No specific biomarkers are identified and the diagnosis is solely based on impaired oxygenation.

The purpose of the present study is to identify biomarkers of inflammation and coagulation in blood withdrawn simultaneous from the pulmonary artery and the left atrium during surgery and up to 20 hours after weaning from cardiopulmonary bypass.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Elective surgery

- CABG

- In treatment with statins

Exclusion Criteria:

- Acute surgery

- Valve replacement

- In treatment with immunodepressive drugs

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No treatment

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Aalborg Universitetshospital Aalborg University

Outcome

Type Measure Description Time frame Safety issue
Primary Acute lung injury measured as the fraction of partial pressure of oxygen divided by the fraction of inspired oxygen Arterial blood gas analysis Evaluated 72 hours after weaning from cardiopulmonary bypass (CPB) No
Secondary Interleukin-1beta Measured in blood samples from radial artery, pulmonary artery and left atrium The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB No
Secondary Interleukin-2 Measured in blood samples from radial artery, pulmonary artery and left atrium The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB No
Secondary Interleukin-4 Measured in blood samples from radial artery, pulmonary artery and left atrium The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB No
Secondary Interleukin-6 Measured in blood samples from radial artery, pulmonary artery and left atrium The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB No
Secondary Interleukin-8 Measured in blood samples from radial artery, pulmonary artery and left atrium The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB No
Secondary Interleukin-10 Measured in blood samples from radial artery, pulmonary artery and left atrium The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB No
Secondary Tumor necroting factor-alpha Measured in blood samples from radial artery, pulmonary artery and left atrium The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB No
Secondary Interferon-gamma Measured in blood samples from radial artery, pulmonary artery and left atrium The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB No
Secondary Granulocyte-macrophage colony-stimulating factor Measured in blood samples from radial artery, pulmonary artery and left atrium The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB No
Secondary Thrombin-antithrombin complexes Measured in blood samples from pulmonary artery and left atrium The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB No
Secondary Plasmin-antiplasmin complexes Measured in blood samples from pulmonary artery and left atrium The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB No
Secondary D-dimer Measured in blood samples from pulmonary artery and left atrium The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB No
Secondary Thrombin Fragment 1.2 Measured in blood samples from pulmonary artery and left atrium The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB No
Secondary Metabolomics Metabolomics using the NMR-technique in blood samples from radial artery, pulmonary artery and left atrium The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB No
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