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Completed

NCT Number: NCT02918877

Anesthetics to Prevent Lung Injury in Cardiac Surgery

The purpose of this study is to investigate whether the use of inhaled anesthetics, compared to intravenous anesthetics, can affect the amount of lung inflammation and postoperative respiratory complications seen after cardiac surgery.

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Key information

Conditions

Inflammatory Lung Injury Ischemia-Reperfusion Lung Injury Postoperative Pulmonary Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

Randomized, controlled trial involving 45 adult patients undergoing cardiac surgery with cardiopulmonary bypass. Patients will be randomized to receive either inhaled anesthesia with sevoflurane or total intravenous anesthesia (TIVA) with propofol for the maintenance phase of their cardiac anesthetic. Assessment of lung inflammation will take place using fiberoptic bronchoscopic sampling of lung fluid as well as serum collection before and after exposure to cardiopulmonary bypass, and the incidence of compositive postoperative pulmonary complications will take place in the postoperative period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (age 18+)
  • Undergoing cardiac surgery with cardiopulmonary bypass

Exclusion criteria

  • Emergency surgery
  • History of severe COPD, emphysema, or ILD
  • Recent (<2wk) or current use of systemic glucocorticoids
  • Prior history of pneumothorax
  • Allergy/contraindication to intravenous anesthetics
  • Personal or family history of malignant hyperthermia or high risk for malignant hyperthermia

Treatment and study plan

Sevoflurane

Drug

Volatile Anesthetic

Propofol

Drug

Intravenous Anesthetic

Other names: Diprivan

Primary outcomes

  1. Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)

    Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

    Inflammatory mediator found in BAL fluid during lung inflammation

Secondary outcomes

  1. Number of Patients With Postoperative Pulmonary Complications

    Time frame: Assessed daily, beginning on the first day after surgery, until hospital discharge or death. On average at our institution, most patients are discharged within 7 days so this is the expected time frame for follow up.

    Composite endpoint of clinically relevant pulmonary complications

  2. BAL Concentration of IL1b (pg/mL)

    Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

    Inflammatory mediator found in BAL fluid during lung inflammation

  3. BAL Concentration of IL6 (pg/mL)

    Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

    Inflammatory mediator found in BAL fluid during lung inflammation

  4. BAL Concentration of IL8 (pg/mL)

    Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

    Inflammatory mediator found in BAL fluid during lung inflammation

  5. BAL Concentration of MCP1 (pg/mL)

    Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

    Inflammatory mediator found in BAL fluid during lung inflammation

  6. BAL Concentration of sRAGE (pg/mL)

    Time frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

    Biomarker of lung injury (RAGE - receptor for advance glycosylation end products)

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Acronym: APLICS

Important dates

Study start
2017
Primary completion
2018
Study completion
2021
First posted
Sep 29, 2016
Registry last updated
May 5, 2021

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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