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Anesthetics to Prevent Lung Injury in Cardiac Surgery

Phase 1
Completed
Conditions
Inflammatory Lung Injury
Ischemia-Reperfusion Lung Injury
Postoperative Pulmonary Complications
Interventions
Registration Number
NCT02918877
Lead Sponsor
Beth Israel Deaconess Medical Center
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
51
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Inhaled AnesthesiaSevofluranePatients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Intravenous AnesthesiaPropofolPatients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Primary Outcome Measures
NameTimeMethod
Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

Inflammatory mediator found in BAL fluid during lung inflammation

Secondary Outcome Measures
NameTimeMethod
Number of Patients With Postoperative Pulmonary ComplicationsAssessed 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

BAL Concentration of IL1b (pg/mL)Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

Inflammatory mediator found in BAL fluid during lung inflammation

BAL Concentration of IL6 (pg/mL)Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

Inflammatory mediator found in BAL fluid during lung inflammation

BAL Concentration of IL8 (pg/mL)Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

Inflammatory mediator found in BAL fluid during lung inflammation

BAL Concentration of MCP1 (pg/mL)Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

Inflammatory mediator found in BAL fluid during lung inflammation

BAL Concentration of sRAGE (pg/mL)Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

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

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center

🇺🇸

Boston, Massachusetts, United States

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