Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS)

April 12, 2021 updated by: Brian O'Gara, Beth Israel Deaconess Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhaled Anesthesia
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Drug: Sevoflurane
Volatile Anesthetic
Active Comparator: Intravenous Anesthesia
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Drug: Propofol
Intravenous Anesthetic
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)
Time Frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Inflammatory mediator found in BAL fluid during lung inflammation
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Postoperative 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.
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.
BAL Concentration of IL1b (pg/mL)
Time Frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Inflammatory mediator found in BAL fluid during lung inflammation
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
BAL Concentration of IL6 (pg/mL)
Time Frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Inflammatory mediator found in BAL fluid during lung inflammation
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
BAL Concentration of IL8 (pg/mL)
Time Frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Inflammatory mediator found in BAL fluid during lung inflammation
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
BAL Concentration of MCP1 (pg/mL)
Time Frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Inflammatory mediator found in BAL fluid during lung inflammation
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
BAL Concentration of sRAGE (pg/mL)
Time Frame: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Biomarker of lung injury (RAGE - receptor for advance glycosylation end products)
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2017

Primary Completion (Actual)

December 24, 2018

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimate)

September 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P000306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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