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
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Inflammatory Lung Injury
• Ischemia
• Ischemia-Reperfusion Lung Injury
• Lung Injury
• Postoperative Pulmonary Complications
• Wounds and Injuries

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