Clinical trial NCT02918877: Anesthetics to Prevent Lung Injury in Cardiac Surgery
Official title: Anesthetics to Prevent Lung Injury in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Inflammatory Lung Injury
Ischemia-Reperfusion Lung Injury
Postoperative Pulmonary Complications
Keywords: Volatile Anesthetics
Intravenous Anesthetics
Inflammatory Lung Injury
Postoperative Pulmonary Complications
Cardiac Surgery
Cardiopulmonary Bypass
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)
timeFrame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Secondary outcomes:
measure: Number of Patients With Postoperative Pulmonary Complications
timeFrame: 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.
measure: BAL Concentration of IL1b (pg/mL)
timeFrame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
measure: BAL Concentration of IL6 (pg/mL)
timeFrame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
measure: BAL Concentration of IL8 (pg/mL)
timeFrame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
measure: BAL Concentration of MCP1 (pg/mL)
timeFrame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
measure: BAL Concentration of sRAGE (pg/mL)
timeFrame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Brian O'Gara, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Gara B, Subramaniam B, Shaefi S, Mueller A, Banner-Goodspeed V, Talmor D. Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS): a protocol for a randomized controlled trial. Trials. 2019 May 31;20(1):312. doi: 10.1186/s13063-019-3400-x.