Anesthetics to Prevent Lung Injury in Cardiac Surgery

Beth Israel Deaconess Medical Center51 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Inflammatory Lung Injury Ischemia-Reperfusion Lung Injury Postoperative Pulmonary Complications

Interventions

SevofluraneDRUG

Volatile Anesthetic

PropofolDRUG

Intravenous Anesthetic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Inflammatory mediator found in BAL fluid during lung inflammation

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

Secondary Outcomes

Number of Patients With Postoperative Pulmonary Complications

Composite endpoint of clinically relevant 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.

BAL Concentration of IL1b (pg/mL)

Inflammatory mediator found in BAL fluid during lung inflammation

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

BAL Concentration of IL6 (pg/mL)

Inflammatory mediator found in BAL fluid during lung inflammation

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

BAL Concentration of IL8 (pg/mL)

Inflammatory mediator found in BAL fluid during lung inflammation

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

BAL Concentration of MCP1 (pg/mL)

Inflammatory mediator found in BAL fluid during lung inflammation

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

BAL Concentration of sRAGE (pg/mL)

Data from ClinicalTrials.gov

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