Clinical trial NCT02475694: Acute Lung Injury After Cardiac Surgery: Pathogenesis
Official title: Acute Lung Injury After Cardiac Surgery: Pathogenesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lung Injury
Metabolic Disturbances
Inflammation
Coagulation; Intravascular
Postoperative; Dysfunction Following Cardiac Surgery
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2015-06-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective coronary artery bypass grafting (CABG)

Brief 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.

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The purpose of the present study is to identify biomarkers of inflammation and coagulation in blood withdrawn simultaneous from the pulmonary artery and the left atrium during surgery and up to 20 hours after weaning from cardiopulmonary bypass.

Eligibility criteria: Inclusion Criteria:

* Elective surgery
* CABG
* In treatment with statins

Exclusion Criteria:

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

Primary outcomes:
measure: Acute lung injury measured as the fraction of partial pressure of oxygen divided by the fraction of inspired oxygen
timeFrame: Evaluated 72 hours after weaning from cardiopulmonary bypass (CPB)
Secondary outcomes:
measure: Interleukin-1beta
timeFrame: 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
measure: Interleukin-2
timeFrame: 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
measure: Interleukin-4
timeFrame: 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
measure: Interleukin-6
timeFrame: 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
measure: Interleukin-8
timeFrame: 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
measure: Interleukin-10
timeFrame: 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
measure: Tumor necroting factor-alpha
timeFrame: 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
measure: Interferon-gamma
timeFrame: 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
measure: Granulocyte-macrophage colony-stimulating factor
timeFrame: 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
measure: Thrombin-antithrombin complexes
timeFrame: 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
measure: Plasmin-antiplasmin complexes
timeFrame: 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
measure: D-dimer
timeFrame: 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
measure: Thrombin Fragment 1.2
timeFrame: 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
measure: Metabolomics
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Aalborg University Hospital
name: Bodil S Rasmussen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: