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Completed

NCT Number: NCT02475694

Acute Lung Injury After Cardiac Surgery: Pathogenesis

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.

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Key information

Conditions

Acute Lung Injury Cardiovascular Diseases Coagulation; Intravascular Embolism and Thrombosis Inflammation Lung Diseases Lung Injury Metabolic Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative; Dysfunction Following Cardiac Surgery Respiratory Tract Diseases Thrombosis Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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The purpose of the present study is to identify biomarkers of inflammation and coagulation in blood withdrawn simultaneous from the pulmonary artery and the left atrium during surgery and up to 20 hours after weaning from cardiopulmonary bypass.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective surgery
  • CABG
  • In treatment with statins

Exclusion criteria

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

Treatment and study plan

No intervention

Other

No treatment

Primary outcomes

  1. Acute lung injury measured as the fraction of partial pressure of oxygen divided by the fraction of inspired oxygen

    Time frame: Evaluated 72 hours after weaning from cardiopulmonary bypass (CPB)

    Arterial blood gas analysis

Secondary outcomes

  1. Interleukin-1beta

    Time frame: 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

    Measured in blood samples from radial artery, pulmonary artery and left atrium

  2. Interleukin-2

    Time frame: 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

    Measured in blood samples from radial artery, pulmonary artery and left atrium

  3. Interleukin-4

    Time frame: 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

    Measured in blood samples from radial artery, pulmonary artery and left atrium

  4. Interleukin-6

    Time frame: 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

    Measured in blood samples from radial artery, pulmonary artery and left atrium

  5. Interleukin-8

    Time frame: 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

    Measured in blood samples from radial artery, pulmonary artery and left atrium

  6. Interleukin-10

    Time frame: 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

    Measured in blood samples from radial artery, pulmonary artery and left atrium

  7. Tumor necroting factor-alpha

    Time frame: 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

    Measured in blood samples from radial artery, pulmonary artery and left atrium

  8. Interferon-gamma

    Time frame: 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

    Measured in blood samples from radial artery, pulmonary artery and left atrium

  9. Granulocyte-macrophage colony-stimulating factor

    Time frame: 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

    Measured in blood samples from radial artery, pulmonary artery and left atrium

  10. Thrombin-antithrombin complexes

    Time frame: 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

    Measured in blood samples from pulmonary artery and left atrium

  11. Plasmin-antiplasmin complexes

    Time frame: 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

    Measured in blood samples from pulmonary artery and left atrium

  12. D-dimer

    Time frame: 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

    Measured in blood samples from pulmonary artery and left atrium

  13. Thrombin Fragment 1.2

    Time frame: 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

    Measured in blood samples from pulmonary artery and left atrium

  14. Metabolomics

    Time frame: 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

    Metabolomics using the NMR-technique in blood samples from radial artery, pulmonary artery and left atrium

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Aalborg University

Registry information

Acronym: ALI

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 19, 2015
Registry last updated
Jun 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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