Acute Lung Injury After Cardiac Surgery: Pathogenesis (ALI)

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Acute Lung Injury; Postoperative; Dysfunction Following Cardiac Surgery; Coagulation; Intravascular; Metabolic Disturbances
• Intervention / Treatment: Other: No intervention

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The purpose of the present study is to identify biomarkers of inflammation and coagulation in blood withdrawn simultaneous from the pulmonary artery and the left atrium during surgery and up to 20 hours after weaning from cardiopulmonary bypass.

• Study Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective coronary artery bypass grafting (CABG)

Description

Inclusion Criteria:

• Elective surgery
• CABG
• In treatment with statins

Exclusion Criteria:

• Acute surgery
• Valve replacement
• In treatment with immunodepressive drugs

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Aalborg University
• Investigators: Principal Investigator: Bodil S Rasmussen, MD, PhD, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: May 21, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (Estimate): June 19, 2015

Study Record Updates

• Last Update Posted (Estimate): June 19, 2015
• Last Update Submitted That Met QC Criteria: June 16, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Thoracic Injuries; Inflammation; Wounds and Injuries; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: N-20080016