Acute Lung Injury After Cardiac Surgery: Pathogenesis

Inflammation Clinical Trial

— ALI  

Official title:

Acute Lung Injury After Cardiac Surgery: Pathogenesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475694
• Other study ID #: N-20080016
• 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The purpose of the present study is to identify biomarkers of inflammation and coagulation in blood withdrawn simultaneous from the pulmonary artery and the left atrium during surgery and up to 20 hours after weaning from cardiopulmonary bypass.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

• Acute Lung Injury
• Coagulation; Intravascular
• Inflammation
• Lung Injury
• Metabolic Disturbances
• Postoperative; Dysfunction Following Cardiac Surgery
• Respiratory Distress Syndrome, Adult

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