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NCT02918877 Clinical Trial

Anesthetics to Prevent Lung Injury in Cardiac Surgery

Postoperative Pulmonary Complications Clinical Trial

— APLICS  

Official title:
Anesthetics to Prevent Lung Injury in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02918877
Other study ID # 2016P000306
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date June 9, 2017
Est. completion date February 1, 2021

Study information
Verified date April 2021
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 51
Est. completion date February 1, 2021
Est. primary completion date December 24, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Sevoflurane
Volatile Anesthetic
• Propofol
Intravenous Anesthetic

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL) Inflammatory mediator found in BAL fluid during lung inflammation Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Secondary Number of Patients With Postoperative Pulmonary Complications Composite endpoint of clinically relevant pulmonary complications 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.
Secondary BAL Concentration of IL1b (pg/mL) Inflammatory mediator found in BAL fluid during lung inflammation Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Secondary BAL Concentration of IL6 (pg/mL) Inflammatory mediator found in BAL fluid during lung inflammation Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Secondary BAL Concentration of IL8 (pg/mL) Inflammatory mediator found in BAL fluid during lung inflammation Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Secondary BAL Concentration of MCP1 (pg/mL) Inflammatory mediator found in BAL fluid during lung inflammation Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Secondary BAL Concentration of sRAGE (pg/mL) Biomarker of lung injury (RAGE - receptor for advance glycosylation end products) Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
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