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Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS)

Primary Purpose

Inflammatory Lung Injury, Ischemia-Reperfusion Lung Injury, Postoperative Pulmonary Complications

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sevoflurane
Propofol
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammatory Lung Injury focused on measuring Volatile Anesthetics, Intravenous Anesthetics, Inflammatory Lung Injury, Postoperative Pulmonary Complications, Cardiac Surgery, Cardiopulmonary Bypass

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inhaled Anesthesia

Intravenous Anesthesia

Arm Description

Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.

Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.

Outcomes

Primary Outcome Measures

Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)
Inflammatory mediator found in BAL fluid during lung inflammation

Secondary Outcome Measures

Number of Patients With Postoperative Pulmonary Complications
Composite endpoint of clinically relevant pulmonary complications
BAL Concentration of IL1b (pg/mL)
Inflammatory mediator found in BAL fluid during lung inflammation
BAL Concentration of IL6 (pg/mL)
Inflammatory mediator found in BAL fluid during lung inflammation
BAL Concentration of IL8 (pg/mL)
Inflammatory mediator found in BAL fluid during lung inflammation
BAL Concentration of MCP1 (pg/mL)
Inflammatory mediator found in BAL fluid during lung inflammation
BAL Concentration of sRAGE (pg/mL)
Biomarker of lung injury (RAGE - receptor for advance glycosylation end products)

Full Information

First Posted
August 30, 2016
Last Updated
April 12, 2021
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02918877
Brief Title
Anesthetics to Prevent Lung Injury in Cardiac Surgery
Acronym
APLICS
Official Title
Anesthetics to Prevent Lung Injury in Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 9, 2017 (Actual)
Primary Completion Date
December 24, 2018 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled Anesthesia
Arm Type
Experimental
Arm Description
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Arm Title
Intravenous Anesthesia
Arm Type
Active Comparator
Arm Description
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Volatile Anesthetic
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
Intravenous Anesthetic
Primary Outcome Measure Information:
Title
Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)
Description
Inflammatory mediator found in BAL fluid during lung inflammation
Time Frame
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Secondary Outcome Measure Information:
Title
Number of Patients With Postoperative Pulmonary Complications
Description
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.
Title
BAL Concentration of IL1b (pg/mL)
Description
Inflammatory mediator found in BAL fluid during lung inflammation
Time Frame
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Title
BAL Concentration of IL6 (pg/mL)
Description
Inflammatory mediator found in BAL fluid during lung inflammation
Time Frame
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Title
BAL Concentration of IL8 (pg/mL)
Description
Inflammatory mediator found in BAL fluid during lung inflammation
Time Frame
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Title
BAL Concentration of MCP1 (pg/mL)
Description
Inflammatory mediator found in BAL fluid during lung inflammation
Time Frame
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Title
BAL Concentration of sRAGE (pg/mL)
Description
Biomarker of lung injury (RAGE - receptor for advance glycosylation end products)
Time Frame
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian O'Gara, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31151474
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.
Results Reference
derived

Learn more about this trial

Anesthetics to Prevent Lung Injury in Cardiac Surgery

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